## Protocol Section
### Identification Module
**NCT ID:** NCT02040779

**Brief Title:** A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma

**Official Title:** A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma

#### Organization Study ID Info
**ID:** BDB-AS-304
#### Organization
**Class:** INDUSTRY
**Full Name:** Teva Branded Pharmaceutical Products R&D, Inc.
### Status Module
#### Completion Date
**Date:** 2014-12-24

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2015-06-19

**Type:** ESTIMATED

**Disp First Submit Date:** 2015-05-21
**Disp First Submit QC Date:** 2015-05-21

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-11-09

**Type:** ACTUAL

**Last Update Submit Date:** 2021-11-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-12-24

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-12-11

**Type:** ACTUAL

**Results First Submit Date:** 2017-10-10

**Results First Submit QC Date:** 2017-11-07

#### Start Date
**Date:** 2013-12-26

**Status Verified Date:** 2021-11

#### Study First Post Date
**Date:** 2014-01-20
**Type:** ESTIMATED
**Study First Submit Date:** 2014-01-16
**Study First Submit QC Date:** 2014-01-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Teva Branded Pharmaceutical Products R&D, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study

### Conditions Module

**Conditions:**

- Persistent Asthma

**Keywords:**

- asthma

- breath-actuated inhaler

- beclomethasone

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 273

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.

**Intervention Names:**

- Drug: Beclomethasone dipropionate breath-actuated inhaler

- Drug: albuterol/salbutamol

**Label:** BDP 80 mcg BAI

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.

**Intervention Names:**

- Drug: Beclomethasone dipropionate breath-actuated inhaler

- Drug: albuterol/salbutamol

**Label:** BDP 160 mcg BAI

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Placebo breath-actuated inhaler (BAI) twice daily.

**Intervention Names:**

- Drug: Placebo breath-actuated inhaler

- Drug: albuterol/salbutamol

**Label:** Placebo BAI

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BDP 160 mcg BAI

- BDP 80 mcg BAI

**Description:** Beclomethasone dipropionate (BDP) breath-actuated inhaler (BAI) given in dosages of either 40 mcg/inhalation or 80 mcg/inhalation. Study drug was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.

**Name:** Beclomethasone dipropionate breath-actuated inhaler

**Other Names:**

- BDP

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo BAI

**Description:** Placebo was provided in matching breath-actuated inhaler (BAI) devices. The placebo devices were identical to the devices used to deliver active drug. Placebo was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.

**Name:** Placebo breath-actuated inhaler

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- BDP 160 mcg BAI

- BDP 80 mcg BAI

- Placebo BAI

**Description:** Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period

**Name:** albuterol/salbutamol

**Other Names:**

- bronchodilators

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-12wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit (Day 1), each treatment visit (Weeks 2, 4, 8 and 12) and any unscheduled visit (such as the early termination visit). This summary is based on observed values recorded as 'best attempt'.

The least-square (LS) means, difference of LS means and its 95% confidence interval (CI), and p-value represent the results obtained from the analysis of covariance with covariate adjustment for baseline, sex, age, current asthma therapy, and treatment.

**Measure:** Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 12 Weeks (AUEC(0-12wk)) by Actual Treatment Received

**Time Frame:** Baseline (Day 1 predose), weeks 2, 4, 8 and 12

#### Secondary Outcomes

**Description:** Change from baseline in the weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF by handheld spirometer over the 12-week treatment period.

PEF were determined twice daily, in the morning and in the evening, before administration of study drug or rescue medications. A handheld spirometer was provided to patients and used to determine the morning and evening PEF throughout the study. The spirometer was programmed to record the highest PEF obtained from 3 valid attempts.

Baseline was defined as the average of recorded trough morning PEF assessments over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit.

The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.

**Measure:** Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 12-Week Treatment Period

**Time Frame:** Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

**Description:** A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary.

Baseline in evening PEF is defined as the average of recorded evening PEF assessments over the 7-day window before randomization.

The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.

**Measure:** Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period

**Time Frame:** Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

**Description:** Change from baseline in the use of rescue medication, albuterol/salbutamol, during the treatment period offers an indication of asthma control.

The LS means, difference of LS means and its 95% CI, and p-value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week and treatment by week interaction.

Baseline was defined as the average of recorded daily usage of albuterol/salbutamol inhalation aerosol over the 7 days prior to the first dose of double-blind study treatment, including morning usage at the randomization visit.

**Measure:** Change From Baseline in Weekly Average of Total Daily Use of Albuterol/Salbutamol Inhalation Aerosol Over Weeks 1-12

**Time Frame:** Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

**Description:** Asthma symptom scores were recorded in the patient's diary each morning and evening before determining FEV1 and PEF and before administration of study or rescue medications.

The Daytime Symptom Score was recorded in the evening on a scale of 0 (No symptoms during the day) to 5 (Symptoms so severe that I could not go to work or perform normal daily activities) plus the Nighttime Symptom Score in the morning on a scale of 0 (No symptoms during the night) to 4 (Symptoms so severe that I did not sleep at all) for a total score range of 0-9.

Baseline was defined as the average of recorded daily asthma symptom scores (average of daytime and nighttime score) over the 7 days prior to the first dose of study treatment, including the morning assessment at the randomization visit.

The LS means, difference of LS means and its 95% CI, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy,

**Measure:** Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 12-Week Treatment Period

**Time Frame:** Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

**Description:** The time to patient study drug treatment withdrawal due to worsening asthma was defined as the number of days elapsed from the date of randomization to the date of withdrawal due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety.

An example of alert criteria is:

* FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1).
* Other criteria as defined in the protocol.

**Measure:** Kaplan-Meier Estimates of Time to Study Drug Treatment Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period

**Time Frame:** Treatment period: daily from Day 1 up to Week 12

**Description:** A count of participants who were withdrawn from the study due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety.

An example of alert criteria is:

* FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1).
* Other criteria as defined in the protocol.

**Measure:** Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period

**Time Frame:** Treatment period: Day 1 up to Week 12

**Description:** An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent 1 of the outcomes listed in this definition.

**Measure:** Participants With Treatment-Emergent Adverse Events (TEAEs)

**Time Frame:** Day 1 up to Week 12

**Description:** Criteria for the select vital signs that showed a potentially clinically relevant abnormal result are:

* Sitting systolic BP (low); \<=90 mm Hg and decrease of \>=20 mm Hg from baseline
* Sitting diastolic BP (high): \>=105 mm Hg and increase of \>=15 mm Hg from baseline

Baseline is defined as the last available assessment prior to the first dose of double-blind study treatment (usually Day 1 predose).

**Measure:** Participants With Potentially Clinically Relevant Abnormal Vital Sign Results During the Treatment Period

**Time Frame:** Baseline (Day 1 predose), Visits at weeks 2, 4, 8, 12

**Description:** Oropharyngeal examinations were performed at every visit by a qualified healthcare professional: during treatment visits are summarized. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area for culturing. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation.

**Measure:** Participants With Findings During Oropharyngeal Examination During Treatment

**Time Frame:** Visits at weeks 2, 4, 8, 12

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Severity of Disease: The patient has persistent asthma, with an forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) reference values at screening visit (SV) (Hankinson et al 1999).
* Current asthma therapy: The patient is currently being treated with 1 of the following:

  1) inhaled corticosteroids (ICSs) at a stable daily dose of less than or equal to 220 mcg/day fluticasone propionate via metered dose inhaler (MDI) or equivalent for a minimum of 4 weeks (28 days) before screening visit, or 2) a stable daily dosage of non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones, or short-acting beta-2 agonists (SABAs) alone or in combination for a minimum of 4 weeks (28 days) before screening visit (SV).
* Reversibility of disease: The patient has demonstrated at least 15% and at least 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at SV or on retesting. - Other criteria apply, please contact the investigator for more information

Exclusion Criteria:

* The patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures.
* The patient is a pregnant or lactating female or plans to become pregnant.
* The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
* The patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient may not have used tobacco products within the past year.
* The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before SV, or has had any hospitalization for asthma within 2 months before SV.
* The patient has historical or current evidence of a clinically significant disease. Significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
* Other criteria apply, please contact the investigator for more information

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Huntington Beach

**Country:** United States

**Facility:** Teva Investigational Site 12813

**State:** California

**Location 2:**

**City:** Mission Viejo

**Country:** United States

**Facility:** Teva Investigational Site 10944

**State:** California

**Location 3:**

**City:** Orange

**Country:** United States

**Facility:** Teva Investigational Site 10946

**State:** California

**Location 4:**

**City:** Rolling Hills Estates

**Country:** United States

**Facility:** Teva Investigational Site 10963

**State:** California

**Location 5:**

**City:** San Diego

**Country:** United States

**Facility:** Teva Investigational Site 10960

**State:** California

**Location 6:**

**City:** San Diego

**Country:** United States

**Facility:** Teva Investigational Site 10973

**State:** California

**Location 7:**

**City:** San Jose

**Country:** United States

**Facility:** Teva Investigational Site 10975

**State:** California

**Location 8:**

**City:** Centennial

**Country:** United States

**Facility:** Teva Investigational Site 10948

**State:** Colorado

**Location 9:**

**City:** Centennial

**Country:** United States

**Facility:** Teva Investigational Site 10958

**State:** Colorado

**Location 10:**

**City:** Colorado Springs

**Country:** United States

**Facility:** Teva Investigational Site 10957

**State:** Colorado

**Location 11:**

**City:** Sarasota

**Country:** United States

**Facility:** Teva Investigational Site 12814

**State:** Florida

**Location 12:**

**City:** Tallahassee

**Country:** United States

**Facility:** Teva Investigational Site 10962

**State:** Florida

**Location 13:**

**City:** Savannah

**Country:** United States

**Facility:** Teva Investigational Site 12809

**State:** Georgia

**Location 14:**

**City:** Indianapolis

**Country:** United States

**Facility:** Teva Investigational Site 10947

**State:** Indiana

**Location 15:**

**City:** Iowa City

**Country:** United States

**Facility:** Teva Investigational Site 10943

**State:** Iowa

**Location 16:**

**City:** Baltimore

**Country:** United States

**Facility:** Teva Investigational Site 10954

**State:** Maryland

**Location 17:**

**City:** Bethesda

**Country:** United States

**Facility:** Teva Investigational Site 12940

**State:** Maryland

**Location 18:**

**City:** North Dartmouth

**Country:** United States

**Facility:** Teva Investigational Site 10955

**State:** Massachusetts

**Location 19:**

**City:** Minneapolis

**Country:** United States

**Facility:** Teva Investigational Site 10941

**State:** Minnesota

**Location 20:**

**City:** Columbia

**Country:** United States

**Facility:** Teva Investigational Site 10970

**State:** Missouri

**Location 21:**

**City:** Rolla

**Country:** United States

**Facility:** Teva Investigational Site 10968

**State:** Missouri

**Location 22:**

**City:** Bozeman

**Country:** United States

**Facility:** Teva Investigational Site 10972

**State:** Montana

**Location 23:**

**City:** Missoula

**Country:** United States

**Facility:** Teva Investigational Site 12941

**State:** Montana

**Location 24:**

**City:** Bellevue

**Country:** United States

**Facility:** Teva Investigational Site 10942

**State:** Nebraska

**Location 25:**

**City:** Skillman

**Country:** United States

**Facility:** Teva Investigational Site 10959

**State:** New Jersey

**Location 26:**

**City:** Raleigh

**Country:** United States

**Facility:** Teva Investigational Site 10945

**State:** North Carolina

**Location 27:**

**City:** Cincinnati

**Country:** United States

**Facility:** Teva Investigational Site 12810

**State:** Ohio

**Location 28:**

**City:** Sylvania

**Country:** United States

**Facility:** Teva Investigational Site 10974

**State:** Ohio

**Location 29:**

**City:** Oklahoma City

**Country:** United States

**Facility:** Teva Investigational Site 12805

**State:** Oklahoma

**Location 30:**

**City:** Oklahoma City

**Country:** United States

**Facility:** Teva Investigational Site 12942

**State:** Oklahoma

**Location 31:**

**City:** Tulsa

**Country:** United States

**Facility:** Teva Investigational Site 10951

**State:** Oklahoma

**Location 32:**

**City:** Lake Oswego

**Country:** United States

**Facility:** Teva Investigational Site 10940

**State:** Oregon

**Location 33:**

**City:** Medford

**Country:** United States

**Facility:** Teva Investigational Site 10952

**State:** Oregon

**Location 34:**

**City:** Portland

**Country:** United States

**Facility:** Teva Investigational Site 10956

**State:** Oregon

**Location 35:**

**City:** Pittsburgh

**Country:** United States

**Facility:** Teva Investigational Site 12939

**State:** Pennsylvania

**Location 36:**

**City:** Orangeburg

**Country:** United States

**Facility:** Teva Investigational Site 12806

**State:** South Carolina

**Location 37:**

**City:** Knoxville

**Country:** United States

**Facility:** Teva Investigational Site 12811

**State:** Tennessee

**Location 38:**

**City:** Austin

**Country:** United States

**Facility:** Teva Investigational Site 10969

**State:** Texas

**Location 39:**

**City:** Boerne

**Country:** United States

**Facility:** Teva Investigational Site 12812

**State:** Texas

**Location 40:**

**City:** Dallas

**Country:** United States

**Facility:** Teva Investigational Site 10949

**State:** Texas

**Location 41:**

**City:** El Paso

**Country:** United States

**Facility:** Teva Investigational Site 10953

**State:** Texas

**Location 42:**

**City:** Houston

**Country:** United States

**Facility:** Teva Investigational Site 12807

**State:** Texas

**Location 43:**

**City:** New Braunfels

**Country:** United States

**Facility:** Teva Investigational Site 10950

**State:** Texas

**Location 44:**

**City:** San Antonio

**Country:** United States

**Facility:** Teva Investigational Site 10961

**State:** Texas

**Location 45:**

**City:** Waco

**Country:** United States

**Facility:** Teva Investigational Site 12808

**State:** Texas

**Location 46:**

**City:** Seattle

**Country:** United States

**Facility:** Teva Investigational Site 10967

**State:** Washington

**Location 47:**

**City:** Greenfield

**Country:** United States

**Facility:** Teva Investigational Site 10964

**State:** Wisconsin

#### Overall Officials

**Official 1:**

**Affiliation:** Teva Branded Pharmaceutical Products R&D, Inc.

**Name:** Medical Director, MD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Hampel FC Jr, Carr W, Gillespie M, Small CJ. Evaluation of beclomethasone dipropionate (80 and 160 micrograms/day) delivered via a breath-actuated inhaler for persistent asthma. Allergy Asthma Proc. 2017 Nov 8;38(6):419-430. doi: 10.2500/aap.2017.38.4089. Epub 2017 Sep 8.

**PMID:** 28886758

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4556

- Name: Asthma

- Relevance: HIGH

- As Found: Asthma

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001249

- Term: Asthma

### Intervention Browse Module - Ancestors

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018927

- Term: Anti-Asthmatic Agents

- ID: D000019141

- Term: Respiratory System Agents

- ID: D000015149

- Term: Tocolytic Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000058666

- Term: Adrenergic beta-2 Receptor Agonists

- ID: D000000318

- Term: Adrenergic beta-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

### Intervention Browse Module - Browse Leaves

- ID: M3767

- Name: Albuterol

- Relevance: HIGH

- As Found: Diameter

- ID: M4800

- Name: Beclomethasone

- Relevance: HIGH

- As Found: Timed

- ID: M5269

- Name: Bronchodilator Agents

- Relevance: HIGH

- As Found: Pain level

- ID: M20963

- Name: Anti-Asthmatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21137

- Name: Respiratory System Agents

- Relevance: LOW

- As Found: Unknown

- ID: M17869

- Name: Tocolytic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3670

- Name: Adrenergic beta-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001507

- Term: Beclomethasone

- ID: D000000420

- Term: Albuterol

- ID: D000001993

- Term: Bronchodilator Agents

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Placebo BAI

**Deaths Num At Risk:** 91

**Description:** Placebo breath-actuated inhaler (BAI) twice daily.

**ID:** EG000

**Other Num at Risk:** 91

**Serious Number Affected:** 1

**Serious Number At Risk:** 91

**Title:** Placebo BAI

**Group ID:** EG001

**Title:** BDP 80 mcg BAI

**Deaths Num At Risk:** 90

**Description:** 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.

**ID:** EG001

**Other Num at Risk:** 90

**Serious Number At Risk:** 90

**Title:** BDP 80 mcg BAI

**Group ID:** EG002

**Title:** BDP 160 mcg BAI

**Deaths Num At Risk:** 92

**Description:** 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.

**ID:** EG002

**Other Num at Risk:** 92

**Serious Number At Risk:** 92

**Title:** BDP 160 mcg BAI

**Frequency Threshold:** 5

#### Serious Events

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 91

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 90

**Group ID:** EG002

**Num At Risk:** 92

**Term:** Asthma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (16.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 91

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 90

**Group ID:** EG002

**Num At Risk:** 92

**Time Frame:** Day 1 to Week 12

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 91

**Group ID:** BG001

**Value:** 90

**Group ID:** BG002

**Value:** 92

**Group ID:** BG003

**Value:** 273

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo BAI

**Description:** Placebo breath-actuated inhaler (BAI) twice daily.

### Group

**ID:** BG001

**Title:** BDP 80 mcg BAI

**Description:** 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.

### Group

**ID:** BG002

**Title:** BDP 160 mcg BAI

**Description:** 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 14.82

**Value:** 37.2

#### Measurement

**Group ID:** BG001

**Spread:** 15.02

**Value:** 38.8

#### Measurement

**Group ID:** BG002

**Spread:** 16.05

**Value:** 37.4

#### Measurement

**Group ID:** BG003

**Spread:** 15.27

**Value:** 37.8

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 91

**Group ID:** BG001

**Value:** 90

**Group ID:** BG002

**Value:** 92

**Group ID:** BG003

**Value:** 273

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 46

#### Measurement

**Group ID:** BG001

**Value:** 54

#### Measurement

**Group ID:** BG002

**Value:** 56

#### Measurement

**Group ID:** BG003

**Value:** 156

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 45

#### Measurement

**Group ID:** BG001

**Value:** 36

#### Measurement

**Group ID:** BG002

**Value:** 36

#### Measurement

**Group ID:** BG003

**Value:** 117

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 91

**Group ID:** BG001

**Value:** 90

**Group ID:** BG002

**Value:** 92

**Group ID:** BG003

**Value:** 273

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 6

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 14

#### Measurement

**Group ID:** BG003

**Value:** 44

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 73

#### Measurement

**Group ID:** BG001

**Value:** 64

#### Measurement

**Group ID:** BG002

**Value:** 72

#### Measurement

**Group ID:** BG003

**Value:** 209

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 5

#### Measurement

**Group ID:** BG003

**Value:** 13

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 91

**Group ID:** BG001

**Value:** 90

**Group ID:** BG002

**Value:** 92

**Group ID:** BG003

**Value:** 273

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 23.848

**Value:** 82.27

#### Measurement

**Group ID:** BG001

**Spread:** 22.382

**Value:** 85.30

#### Measurement

**Group ID:** BG002

**Spread:** 20.577

**Value:** 80.29

#### Measurement

**Group ID:** BG003

**Spread:** 22.316

**Value:** 82.60

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 91

**Group ID:** BG001

**Value:** 90

**Group ID:** BG002

**Value:** 92

**Group ID:** BG003

**Value:** 273

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.473

**Value:** 169.28

#### Measurement

**Group ID:** BG001

**Spread:** 10.447

**Value:** 170.88

#### Measurement

**Group ID:** BG002

**Spread:** 8.657

**Value:** 168.78

#### Measurement

**Group ID:** BG003

**Spread:** 9.554

**Value:** 169.64

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 90

**Group ID:** BG001

**Value:** 90

**Group ID:** BG002

**Value:** 92

**Group ID:** BG003

**Value:** 272

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 6.9051

**Value:** 28.383

#### Measurement

**Group ID:** BG001

**Spread:** 7.9371

**Value:** 29.266

#### Measurement

**Group ID:** BG002

**Spread:** 6.7751

**Value:** 28.136

#### Measurement

**Group ID:** BG003

**Spread:** 7.2109

**Value:** 28.591

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 90

**Group ID:** BG001

**Value:** 90

**Group ID:** BG002

**Value:** 92

**Group ID:** BG003

**Value:** 272

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** <3 months

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 1

**Category Title:** 3 months to <6 months

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 2

**Category Title:** 6 months to <1 year

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 10

**Category Title:** 1 year to < 5 years

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 10

#### Measurement

**Group ID:** BG003

**Value:** 27

**Category Title:** 5 years to <10 years

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 18

#### Measurement

**Group ID:** BG003

**Value:** 46

**Category Title:** 10 years to <15 years

#### Measurement

**Group ID:** BG000

**Value:** 65

#### Measurement

**Group ID:** BG001

**Value:** 60

#### Measurement

**Group ID:** BG002

**Value:** 62

#### Measurement

**Group ID:** BG003

**Value:** 187

**Category Title:** >=15 years

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 91

**Group ID:** BG001

**Value:** 90

**Group ID:** BG002

**Value:** 92

**Group ID:** BG003

**Value:** 273

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 35

#### Measurement

**Group ID:** BG001

**Value:** 34

#### Measurement

**Group ID:** BG002

**Value:** 35

#### Measurement

**Group ID:** BG003

**Value:** 104

**Category Title:** Inhaled corticosteroid

#### Measurement

**Group ID:** BG000

**Value:** 56

#### Measurement

**Group ID:** BG001

**Value:** 56

#### Measurement

**Group ID:** BG002

**Value:** 57

#### Measurement

**Group ID:** BG003

**Value:** 169

**Category Title:** Non-corticosteroid

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 91

**Group ID:** BG001

**Value:** 90

**Group ID:** BG002

**Value:** 92

**Group ID:** BG003

**Value:** 273

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Weight
**Unit of Measure:** kg
### Measure 5
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** One participant did not have a height recorded
**Title:** Height
**Unit of Measure:** cm
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** One participant did not have a height recorded, therefore BMI could not be calculated.
**Title:** Body Mass Index
**Unit of Measure:** kg/m^2
### Measure 7
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Duration of Asthma
**Unit of Measure:** Participants
### Measure 8
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Current Asthma Therapy
**Unit of Measure:** Participants
**Population Description:** Intent-to-treat (ITT) Population
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** ustevatrials@tevapharm.com
**Organization:** Teva Branded Pharmaceutical Products R&D
**Phone:** 215-591-3000
**Title:** Director, Clinical Research
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.048
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.185
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** BDP 160 mcg BAI - Placebo BAI
**Group Description:** A fixed-sequence multiple testing procedure was used while controlling the family-wise error rate at 5%. If the 2-sided p-value resulting from the ANCOVA model for comparing beclomethasone dipropionate BAI 160 mcg/day versus placebo was less than 0.05, then the comparison of the 80 mcg/day versus placebo was to be interpreted inferentially.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0010
**P-Value Comment:** ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.
**Parameter Type:** LSM difference
**Parameter Value:** 0.116
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.054
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.193
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** BDP 80 mcg BAI - Placebo BAI
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0005
**P-Value Comment:** ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.
**Parameter Type:** LSM difference
**Parameter Value:** 0.124
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 0.202
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 15.621
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** BDP 160 mcg BAI - Placebo BAI
**Group Description:** Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0443
**P-Value Comment:** a priori threshold for significance of 0.05.
**Parameter Type:** LSM difference
**Parameter Value:** 7.911
**Statistical Comment:** 
**Statistical Method:** mixed model for repeated measures
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 5.843
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 21.446
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** BDP 160 mcg BAI - Placebo BAI
**Group Description:** Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0007
**P-Value Comment:** a priori threshold for significance of 0.05.
**Parameter Type:** LSM difference
**Parameter Value:** 13.645
**Statistical Comment:** 
**Statistical Method:** mixed model for repeated measures
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -2.905
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 13.715
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** BDP 160 mcg BAI - Placebo BAI
**Group Description:** Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.2014
**P-Value Comment:** a priori threshold for significance of 0.05.
**Parameter Type:** LSM difference
**Parameter Value:** 5.405
**Statistical Comment:** 
**Statistical Method:** mixed model for repeated measures
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 2.500
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 19.303
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** BDP 160 mcg BAI - Placebo BAI
**Group Description:** Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0112
**P-Value Comment:** a priori threshold for significance of 0.05.
**Parameter Type:** LSM difference
**Parameter Value:** 10.902
**Statistical Comment:** 
**Statistical Method:** mixed model for repeated measures
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -0.708
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.068
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** BDP 160 mcg BAI - Placebo BAI
**Group Description:** Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0175
**P-Value Comment:** a priori threshold for significance of 0.05.
**Parameter Type:** LSM difference
**Parameter Value:** -0.388
**Statistical Comment:** 
**Statistical Method:** mixed model for repeated measures
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.678
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.038
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** BDP 80 mcg BAI - Placebo BAI
**Group Description:** Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0285
**P-Value Comment:** a priori threshold for significance of 0.05.
**Parameter Type:** LSM difference
**Parameter Value:** -0.358
**Statistical Comment:** 
**Statistical Method:** mixed model for repeated measures
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** -0.263
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.011
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** BDP 160 mcg BAI - Placebo BAI
**Group Description:** Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0335
**P-Value Comment:** a priori threshold for significance of 0.05.
**Parameter Type:** LSM difference
**Parameter Value:** -0.137
**Statistical Comment:** 
**Statistical Method:** mixed model for repeated measures
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.255
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.001
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** BDP 80 mcg BAI - Placebo BAI
**Group Description:** Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0509
**P-Value Comment:** a priori threshold for significance of 0.05.
**Parameter Type:** LSM difference
**Parameter Value:** -0.127
**Statistical Comment:** 
**Statistical Method:** mixed model for repeated measures
**Tested Non-Inferiority:** 
### Outcome Measure 6
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.2384
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0208
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0252
- **Upper Limit:** 
- **Value:** 0.048
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.0254
- **Upper Limit:** 
- **Value:** 0.171
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.0248
- **Upper Limit:** 
- **Value:** 0.164
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.8224
- **Upper Limit:** 
- **Value:** -0.795
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.8241
- **Upper Limit:** 
- **Value:** 12.849
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.7735
- **Upper Limit:** 
- **Value:** 7.116
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.0380
- **Upper Limit:** 
- **Value:** -0.797
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 35.0507
- **Upper Limit:** 
- **Value:** 10.105
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.9908
- **Upper Limit:** 
- **Value:** 4.608
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.1162
- **Upper Limit:** 
- **Value:** -0.010
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.1155
- **Upper Limit:** 
- **Value:** -0.368
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.1153
- **Upper Limit:** 
- **Value:** -0.398
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0460
- **Upper Limit:** 
- **Value:** -0.166
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.0463
- **Upper Limit:** 
- **Value:** -0.293
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.0454
- **Upper Limit:** 
- **Value:** -0.304
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** Insufficient number of participants withdrawn
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** Insufficient number of participants withdrawn
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** Insufficient number of participants withdrawn
- **Group ID:** OG002
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-12wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit (Day 1), each treatment visit (Weeks 2, 4, 8 and 12) and any unscheduled visit (such as the early termination visit). This summary is based on observed values recorded as 'best attempt'.

The least-square (LS) means, difference of LS means and its 95% confidence interval (CI), and p-value represent the results obtained from the analysis of covariance with covariate adjustment for baseline, sex, age, current asthma therapy, and treatment.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** The full analysis set (FAS) included all patients in the intent to treat (ITT) population who received at least 1 dose of study drug and had at least 1 postbaseline trough morning (pre-dose and pre-rescue bronchodilator) assessment of FEV1.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 1 predose), weeks 2, 4, 8 and 12
**Title:** Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 12 Weeks (AUEC(0-12wk)) by Actual Treatment Received
**Type:** PRIMARY
**Unit of Measure:** liters
##### Group
**Description:** Placebo breath-actuated inhaler (BAI) twice daily.
**ID:** OG000
**Title:** Placebo BAI
##### Group
**Description:** 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
**ID:** OG001
**Title:** BDP 80 mcg BAI
##### Group
**Description:** 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
**ID:** OG002
**Title:** BDP 160 mcg BAI
#### Outcome Measure 2
**Description:** Change from baseline in the weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF by handheld spirometer over the 12-week treatment period.

PEF were determined twice daily, in the morning and in the evening, before administration of study drug or rescue medications. A handheld spirometer was provided to patients and used to determine the morning and evening PEF throughout the study. The spirometer was programmed to record the highest PEF obtained from 3 valid attempts.

Baseline was defined as the average of recorded trough morning PEF assessments over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit.

The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Full analysis set (FAS)
**Reporting Status:** POSTED
**Time Frame:** Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12
**Title:** Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 12-Week Treatment Period
**Type:** SECONDARY
**Unit of Measure:** L/minute
##### Group
**Description:** Placebo breath-actuated inhaler (BAI) twice daily.
**ID:** OG000
**Title:** Placebo BAI
##### Group
**Description:** 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
**ID:** OG001
**Title:** BDP 80 mcg BAI
##### Group
**Description:** 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
**ID:** OG002
**Title:** BDP 160 mcg BAI
#### Outcome Measure 3
**Description:** A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary.

Baseline in evening PEF is defined as the average of recorded evening PEF assessments over the 7-day window before randomization.

The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Full analysis set
**Reporting Status:** POSTED
**Time Frame:** Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12
**Title:** Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period
**Type:** SECONDARY
**Unit of Measure:** L/minute
##### Group
**Description:** Placebo breath-actuated inhaler (BAI) twice daily.
**ID:** OG000
**Title:** Placebo BAI
##### Group
**Description:** 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
**ID:** OG001
**Title:** BDP 80 mcg BAI
##### Group
**Description:** 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
**ID:** OG002
**Title:** BDP 160 mcg BAI
#### Outcome Measure 4
**Description:** Change from baseline in the use of rescue medication, albuterol/salbutamol, during the treatment period offers an indication of asthma control.

The LS means, difference of LS means and its 95% CI, and p-value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week and treatment by week interaction.

Baseline was defined as the average of recorded daily usage of albuterol/salbutamol inhalation aerosol over the 7 days prior to the first dose of double-blind study treatment, including morning usage at the randomization visit.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** FAS
**Reporting Status:** POSTED
**Time Frame:** Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12
**Title:** Change From Baseline in Weekly Average of Total Daily Use of Albuterol/Salbutamol Inhalation Aerosol Over Weeks 1-12
**Type:** SECONDARY
**Unit of Measure:** inhalations
##### Group
**Description:** Placebo breath-actuated inhaler (BAI) twice daily.
**ID:** OG000
**Title:** Placebo BAI
##### Group
**Description:** 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
**ID:** OG001
**Title:** BDP 80 mcg BAI
##### Group
**Description:** 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
**ID:** OG002
**Title:** BDP 160 mcg BAI
#### Outcome Measure 5
**Description:** Asthma symptom scores were recorded in the patient's diary each morning and evening before determining FEV1 and PEF and before administration of study or rescue medications.

The Daytime Symptom Score was recorded in the evening on a scale of 0 (No symptoms during the day) to 5 (Symptoms so severe that I could not go to work or perform normal daily activities) plus the Nighttime Symptom Score in the morning on a scale of 0 (No symptoms during the night) to 4 (Symptoms so severe that I did not sleep at all) for a total score range of 0-9.

Baseline was defined as the average of recorded daily asthma symptom scores (average of daytime and nighttime score) over the 7 days prior to the first dose of study treatment, including the morning assessment at the randomization visit.

The LS means, difference of LS means and its 95% CI, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy,
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Full analysis set
**Reporting Status:** POSTED
**Time Frame:** Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12
**Title:** Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 12-Week Treatment Period
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Placebo breath-actuated inhaler (BAI) twice daily.
**ID:** OG000
**Title:** Placebo BAI
##### Group
**Description:** 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
**ID:** OG001
**Title:** BDP 80 mcg BAI
##### Group
**Description:** 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
**ID:** OG002
**Title:** BDP 160 mcg BAI
#### Outcome Measure 6
**Description:** The time to patient study drug treatment withdrawal due to worsening asthma was defined as the number of days elapsed from the date of randomization to the date of withdrawal due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety.

An example of alert criteria is:

* FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1).
* Other criteria as defined in the protocol.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Full analysis set
**Reporting Status:** POSTED
**Time Frame:** Treatment period: daily from Day 1 up to Week 12
**Title:** Kaplan-Meier Estimates of Time to Study Drug Treatment Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** Placebo breath-actuated inhaler (BAI) twice daily.
**ID:** OG000
**Title:** Placebo BAI
##### Group
**Description:** 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
**ID:** OG001
**Title:** BDP 80 mcg BAI
##### Group
**Description:** 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
**ID:** OG002
**Title:** BDP 160 mcg BAI
#### Outcome Measure 7
**Description:** A count of participants who were withdrawn from the study due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety.

An example of alert criteria is:

* FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1).
* Other criteria as defined in the protocol.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Full analysis set
**Reporting Status:** POSTED
**Time Frame:** Treatment period: Day 1 up to Week 12
**Title:** Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Placebo breath-actuated inhaler (BAI) twice daily.
**ID:** OG000
**Title:** Placebo BAI
##### Group
**Description:** 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
**ID:** OG001
**Title:** BDP 80 mcg BAI
##### Group
**Description:** 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
**ID:** OG002
**Title:** BDP 160 mcg BAI
#### Outcome Measure 8
**Description:** An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent 1 of the outcomes listed in this definition.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The safety population included all randomly assigned patients (ITT population) who took 1 or more doses of study drug. In this population, treatment was assigned based upon the treatment patients actually received, regardless of the treatment to which they were randomized.
**Reporting Status:** POSTED
**Time Frame:** Day 1 up to Week 12
**Title:** Participants With Treatment-Emergent Adverse Events (TEAEs)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Placebo breath-actuated inhaler (BAI) twice daily.
**ID:** OG000
**Title:** Placebo BAI
##### Group
**Description:** 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
**ID:** OG001
**Title:** BDP 80 mcg BAI
##### Group
**Description:** 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
**ID:** OG002
**Title:** BDP 160 mcg BAI
#### Outcome Measure 9
**Description:** Criteria for the select vital signs that showed a potentially clinically relevant abnormal result are:

* Sitting systolic BP (low); \<=90 mm Hg and decrease of \>=20 mm Hg from baseline
* Sitting diastolic BP (high): \>=105 mm Hg and increase of \>=15 mm Hg from baseline

Baseline is defined as the last available assessment prior to the first dose of double-blind study treatment (usually Day 1 predose).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety population
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 1 predose), Visits at weeks 2, 4, 8, 12
**Title:** Participants With Potentially Clinically Relevant Abnormal Vital Sign Results During the Treatment Period
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Placebo breath-actuated inhaler (BAI) twice daily.
**ID:** OG000
**Title:** Placebo BAI
##### Group
**Description:** 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
**ID:** OG001
**Title:** BDP 80 mcg BAI
##### Group
**Description:** 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
**ID:** OG002
**Title:** BDP 160 mcg BAI
#### Outcome Measure 10
**Description:** Oropharyngeal examinations were performed at every visit by a qualified healthcare professional: during treatment visits are summarized. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area for culturing. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety population
**Reporting Status:** POSTED
**Time Frame:** Visits at weeks 2, 4, 8, 12
**Title:** Participants With Findings During Oropharyngeal Examination During Treatment
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Placebo breath-actuated inhaler (BAI) twice daily.
**ID:** OG000
**Title:** Placebo BAI
##### Group
**Description:** 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
**ID:** OG001
**Title:** BDP 80 mcg BAI
##### Group
**Description:** 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
**ID:** OG002
**Title:** BDP 160 mcg BAI
### Participant Flow Module
#### Group
**Description:** Placebo breath-actuated inhaler (BAI) twice daily.
**ID:** FG000
**Title:** Placebo BAI
#### Group
**Description:** 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
**ID:** FG001
**Title:** BDP 80 mcg BAI
#### Group
**Description:** 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
**ID:** FG002
**Title:** BDP 160 mcg BAI
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
##### Withdraw
**Type:** Non-compliance
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 91
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 90
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 92
##### Milestone
**Type:** Full Analysis Set (FAS)
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 90
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 88
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 92
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 79
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 83
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 88
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 12
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 4
**Recruitment Details:** For this study, 47 sites were activated and screened at least 1 patient, 44 sites screened at least 1 patient who entered the run-in period, and 43 sites randomly assigned a patient. Overall, 273 patients were randomly assigned to treatment
**Has Results:** True