## Protocol Section
### Identification Module
**NCT ID:** NCT01587079

**Brief Title:** Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

**Official Title:** A Randomized, Double Blind, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide 18 µg, Open Label) as Active Control

#### Organization Study ID Info
**ID:** PT003005
#### Organization
**Class:** INDUSTRY
**Full Name:** Pearl Therapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2012-10

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2013-11-14

**Type:** ESTIMATED

**Disp First Submit Date:** 2013-10-22
**Disp First Submit QC Date:** 2013-10-22

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-06-30

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-09

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2016-06-30

**Type:** ESTIMATED

**Results First Submit Date:** 2016-05-23

**Results First Submit QC Date:** 2016-05-23

#### Start Date
**Date:** 2012-04

**Status Verified Date:** 2016-05

#### Study First Post Date
**Date:** 2012-04-27
**Type:** ESTIMATED
**Study First Submit Date:** 2012-04-25
**Study First Submit QC Date:** 2012-04-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pearl Therapeutics, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD

### Conditions Module

**Conditions:**

- Chronic Obstructive Pulmonary Disease

**Keywords:**

- COPD

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 159

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** PT003 MDI Dose 1

**Intervention Names:**

- Drug: PT003

**Label:** PT003 (Dose 1)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** PT003 MDI Dose 2

**Intervention Names:**

- Drug: PT003

**Label:** PT003 (Dose 2)

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** PT003 MDI Dose 3

**Intervention Names:**

- Drug: PT003

**Label:** PT003 (Dose 3)

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** PT003 MDI Dose 4

**Intervention Names:**

- Drug: PT003

**Label:** PT003 (Dose 4)

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** PT003 MDI Dose 5

**Intervention Names:**

- Drug: PT003

**Label:** PT003 (Dose 5)

**Type:** EXPERIMENTAL

#### Arm Group 6

**Description:** PT001 MDI

**Intervention Names:**

- Drug: PT001

**Label:** PT001

**Type:** EXPERIMENTAL

#### Arm Group 7

**Description:** PT005 MDI

**Intervention Names:**

- Drug: PT005

**Label:** PT005

**Type:** EXPERIMENTAL

#### Arm Group 8

**Description:** Tiotropium Bromide

**Intervention Names:**

- Drug: Tiotropium inhalation powder

**Label:** Spiriva® Handihaler®

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- PT003 (Dose 1)

- PT003 (Dose 2)

- PT003 (Dose 3)

- PT003 (Dose 4)

- PT003 (Dose 5)

**Description:** PT003 MDI administered as two puffs BID for 7 days

**Name:** PT003

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- PT001

**Description:** PT001 MDI administered as two puffs BID for 7 days

**Name:** PT001

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- PT005

**Description:** PT005 MDI administered as two puffs BID for 7 days

**Name:** PT005

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Spiriva® Handihaler®

**Description:** Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days

**Name:** Tiotropium inhalation powder

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** FEV1 AUC 0-12

**Measure:** FEV1 AUC 0-12 on Day 7

**Time Frame:** Day 7

#### Secondary Outcomes

**Description:** Peak change from Baseline in FEV1 on Treatment

**Measure:** Peak Change From Baseline in FEV1 on Treatment Day 1

**Time Frame:** Day 1

**Description:** Time to onset of action (\>10% improvement in FEV1)

**Measure:** Time to Onset of Action (>10% Improvement in FEV1) on Day 1

**Time Frame:** Day 1

**Description:** Proportion of subjects achieving \>=12% improvement in FEV1

**Measure:** Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1

**Time Frame:** Day 1

**Description:** Peak change from baseline in Inspiratory Capacity

**Measure:** Peak Change From Baseline in Inspiratory Capacity on Day 1

**Time Frame:** Day 1

**Description:** Change from baseline in morning pre-dose trough FEV1

**Measure:** Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7

**Time Frame:** Day 7

**Description:** Peak change from baseline in FEV1 Day 7

**Measure:** Peak Change From Baseline in FEV1 on Day 7

**Time Frame:** Day 7

**Description:** Change from baseline in morning pre-dose trough IC

**Measure:** Change From Baseline in Morning Pre-dose Trough IC on Day 7

**Time Frame:** Day 7

**Description:** Peak change from baseline IC

**Measure:** Peak Change From Baseline IC on Day 7

**Time Frame:** Day 7

**Description:** Change from baseline at evening 12-hour post-dose trough FEV1

**Measure:** Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7

**Time Frame:** Day 7

**Description:** Change from baseline in mean morning pre-dose daily peak flow readings

**Measure:** Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7

**Time Frame:** Day 7

**Description:** Change from baseline in mean morning post-dose daily peak flow readings on

**Measure:** Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7

**Time Frame:** Day 7

**Description:** Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)

**Measure:** Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7

**Time Frame:** Day 7

**Description:** Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)

**Measure:** Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7

**Time Frame:** Day 7

### Eligibility Module

**Eligibility Criteria:** Key Inclusion Criteria:

* Signed written informed consent
* 40 - 80 years of age
* Clinical history of COPD with airflow limitation that is not fully reversible
* Females of non-child bearing potential or females of child bearing potential with negative pregnancy test and acceptable contraceptive methods
* Current/former smokers with at least a 10 pack-year history of cigarette smoking
* A measured post-bronchodilator FEV1/FVC ratio of \< or = 0.70
* A measured post-bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values
* Able to change COPD treatment as required by protocol

Key Exclusion Criteria:

* Women who are pregnant or lactating
* Primary diagnosis of asthma
* Alpha-1 antitrypsin deficiency as the cause of COPD
* Active pulmonary diseases
* Prior lung volume reduction surgery
* Abnormal chest X-ray not due to the presence of COPD
* Hospitalized due to poorly controlled COPD within 3 months of Screening
* Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
* Cancer that has not been in complete remission for at least 5 years
* Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives

Other inclusion/exclusion criteria as defined in the protocol

**Maximum Age:** 80 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Glendale

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** Arizona

**Location 2:**

**City:** Rancho Mirage

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** California

**Location 3:**

**City:** Waterbury

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** Connecticut

**Location 4:**

**City:** Clearwater

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** Florida

**Zip:** 33765

**Location 5:**

**City:** Clearwater

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** Florida

**Location 6:**

**City:** Pensacola

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** Florida

**Location 7:**

**City:** Winter Park

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** Florida

**Zip:** 32789

**Location 8:**

**City:** Lafayette

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** Louisiana

**Location 9:**

**City:** North Dartmouth

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** Massachusetts

**Location 10:**

**City:** Fridley

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** Minnesota

**Location 11:**

**City:** St. Louis

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** Missouri

**Location 12:**

**City:** Summit

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** New Jersey

**Location 13:**

**City:** Cincinnati

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** Ohio

**Location 14:**

**City:** Medford

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** Oregon

**Zip:** 97504

**Location 15:**

**City:** Medford

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** Oregon

**Location 16:**

**City:** Rock Hill

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** South Carolina

**Location 17:**

**City:** Spartanburg

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** South Carolina

**Zip:** 29303

**Location 18:**

**City:** San Antonio

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** Texas

**Location 19:**

**City:** Morgantown

**Country:** United States

**Facility:** Pearl Investigative Site

**State:** West Virginia

#### Overall Officials

**Official 1:**

**Affiliation:** Pearl Therapeutics, Inc.

**Name:** Colin Reisner, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11168

- Name: Lung Diseases

- Relevance: HIGH

- As Found: Pulmonary Disease

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: HIGH

- As Found: Obstructive Pulmonary Disease

- ID: M23449

- Name: Pulmonary Disease, Chronic Obstructive

- Relevance: HIGH

- As Found: Chronic Obstructive Pulmonary Disease

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008171

- Term: Lung Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000029424

- Term: Pulmonary Disease, Chronic Obstructive

### Intervention Browse Module - Ancestors

- ID: D000001993

- Term: Bronchodilator Agents

- 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: D000010276

- Term: Parasympatholytics

- ID: D000018680

- Term: Cholinergic Antagonists

- ID: D000018678

- Term: Cholinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: AntiConv

- Name: Anticonvulsants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: Resp

- Name: Respiratory System Agents

### Intervention Browse Module - Browse Leaves

- ID: M5241

- Name: Bromides

- Relevance: LOW

- As Found: Unknown

- ID: M9130

- Name: Glycopyrrolate

- Relevance: LOW

- As Found: Unknown

- ID: M304

- Name: Formoterol Fumarate

- Relevance: LOW

- As Found: Unknown

- ID: M416

- Name: Tiotropium Bromide

- Relevance: HIGH

- As Found: Melanoma

- ID: M5269

- Name: Bronchodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20963

- Name: Anti-Asthmatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21137

- Name: Respiratory System Agents

- Relevance: LOW

- As Found: Unknown

- ID: M13189

- Name: Parasympatholytics

- Relevance: LOW

- As Found: Unknown

- ID: M20760

- Name: Cholinergic Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20758

- Name: Cholinergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069447

- Term: Tiotropium Bromide

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Safety Population - All subjects who were randomized, received at least 1 dose of a study treatment, and had a post-baseline safety assessment for that treatment.

#### Event Groups

**Group ID:** EG000

**Title:** GP MDI 18 μg (PT001)

**Description:** 18 μg

**ID:** EG000

**Other Num Affected:** 8

**Other Num at Risk:** 66

**Serious Number Affected:** 1

**Serious Number At Risk:** 66

**Title:** GP MDI 18 μg (PT001)

**Group ID:** EG001

**Title:** GFF MDI 18/9.6 μg (PT003)

**Description:** 18/9.6 μg

**ID:** EG001

**Other Num Affected:** 2

**Other Num at Risk:** 71

**Serious Number Affected:** 1

**Serious Number At Risk:** 71

**Title:** GFF MDI 18/9.6 μg (PT003)

**Group ID:** EG002

**Title:** GFF MDI 9/9.6 μg (PT003)

**Description:** 9/9.6 μg

**ID:** EG002

**Other Num Affected:** 8

**Other Num at Risk:** 70

**Serious Number At Risk:** 70

**Title:** GFF MDI 9/9.6 μg (PT003)

**Group ID:** EG003

**Title:** GFF MDI 4.6/9.6 μg (PT003)

**Description:** 4.6/9.6 μg

**ID:** EG003

**Other Num Affected:** 5

**Other Num at Risk:** 67

**Serious Number At Risk:** 67

**Title:** GFF MDI 4.6/9.6 μg (PT003)

**Group ID:** EG004

**Title:** GFF MDI 2.4/9.6 μg (PT003)

**Description:** 2.4/9.6 μg

**ID:** EG004

**Other Num Affected:** 9

**Other Num at Risk:** 71

**Serious Number Affected:** 1

**Serious Number At Risk:** 71

**Title:** GFF MDI 2.4/9.6 μg (PT003)

**Group ID:** EG005

**Title:** GFF MDI 1.2/9.6 μg (PT003)

**Description:** 1.2/9.6 μg

**ID:** EG005

**Other Num Affected:** 2

**Other Num at Risk:** 68

**Serious Number Affected:** 2

**Serious Number At Risk:** 68

**Title:** GFF MDI 1.2/9.6 μg (PT003)

**Group ID:** EG006

**Title:** FF MDI 9.6 μg (PT005)

**Description:** 9.6 μg

**ID:** EG006

**Other Num Affected:** 8

**Other Num at Risk:** 73

**Serious Number Affected:** 1

**Serious Number At Risk:** 73

**Title:** FF MDI 9.6 μg (PT005)

**Group ID:** EG007

**Title:** Spiriva

**Description:** 18 μg

**ID:** EG007

**Other Num Affected:** 6

**Other Num at Risk:** 71

**Serious Number At Risk:** 71

**Title:** Spiriva

**Frequency Threshold:** 5

#### Other Events

**Term:** Dry Mouth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA

**Term:** Tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA

#### Serious Events

**Term:** Cardio-Respiratory arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Num At Risk:** 66

**Group ID:** EG001

**Num At Risk:** 71

**Group ID:** EG002

**Num At Risk:** 70

**Group ID:** EG003

**Num At Risk:** 67

**Group ID:** EG004

**Num At Risk:** 71

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 68

**Num Events:** 1

**Group ID:** EG006

**Num At Risk:** 73

**Group ID:** EG007

**Num At Risk:** 71

**Term:** Tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Num At Risk:** 66

**Group ID:** EG001

**Num At Risk:** 71

**Group ID:** EG002

**Num At Risk:** 70

**Group ID:** EG003

**Num At Risk:** 67

**Group ID:** EG004

**Num At Risk:** 71

**Group ID:** EG005

**Num Affected:** 1

**Num At Risk:** 68

**Num Events:** 1

**Group ID:** EG006

**Num At Risk:** 73

**Group ID:** EG007

**Num At Risk:** 71

**Term:** Sudden Death

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Num At Risk:** 66

**Group ID:** EG001

**Num At Risk:** 71

**Group ID:** EG002

**Num At Risk:** 70

**Group ID:** EG003

**Num At Risk:** 67

**Group ID:** EG004

**Num At Risk:** 71

**Group ID:** EG005

**Num At Risk:** 68

**Group ID:** EG006

**Num Affected:** 1

**Num At Risk:** 73

**Num Events:** 1

**Group ID:** EG007

**Num At Risk:** 71

**Term:** Spinal Compression fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Num At Risk:** 66

**Group ID:** EG001

**Num At Risk:** 71

**Group ID:** EG002

**Num At Risk:** 70

**Group ID:** EG003

**Num At Risk:** 67

**Group ID:** EG004

**Num Affected:** 1

**Num At Risk:** 71

**Num Events:** 1

**Group ID:** EG005

**Num At Risk:** 68

**Group ID:** EG006

**Num At Risk:** 73

**Group ID:** EG007

**Num At Risk:** 71

**Term:** Transient Ischaemic attack

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Num At Risk:** 66

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 71

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 70

**Group ID:** EG003

**Num At Risk:** 67

**Group ID:** EG004

**Num At Risk:** 71

**Group ID:** EG005

**Num At Risk:** 68

**Group ID:** EG006

**Num At Risk:** 73

**Group ID:** EG007

**Num At Risk:** 71

**Term:** Pneumothorax

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 66

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 71

**Group ID:** EG002

**Num At Risk:** 70

**Group ID:** EG003

**Num At Risk:** 67

**Group ID:** EG004

**Num At Risk:** 71

**Group ID:** EG005

**Num At Risk:** 68

**Group ID:** EG006

**Num At Risk:** 73

**Group ID:** EG007

**Num At Risk:** 71

**Time Frame:** SAEs and AEs were collected throughout study participation and up to 14 days following the last dose of study drug.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 159

**Units:** Participants

### Group

**ID:** BG000

**Title:** All Subjects Screened

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.6

**Value:** 62.8

**Class Title:** Age, years

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 47.8

**Value:** 76

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Spread:** 52.2

**Value:** 83

**Category Title:** Male

**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
**Population Description:** ITT/Safety Population
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** creisner@pearltherapeutics.com
**Organization:** Pearl Therapeutics, Inc
**Phone:** 973-975-0320
**Title:** Colin Resiner, MD, FCCP, FAAAAI
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.415
- **Spread:** 
- **Upper Limit:** 1.489
- **Value:** 1.452
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.554
- **Spread:** 
- **Upper Limit:** 1.628
- **Value:** 1.591
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 1.509
- **Spread:** 
- **Upper Limit:** 1.585
- **Value:** 1.547
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 1.502
- **Spread:** 
- **Upper Limit:** 1.575
- **Value:** 1.539
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 1.502
- **Spread:** 
- **Upper Limit:** 1.575
- **Value:** 1.538
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 1.472
- **Spread:** 
- **Upper Limit:** 1.545
- **Value:** 1.508
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 1.430
- **Spread:** 
- **Upper Limit:** 1.505
- **Value:** 1.467
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 1.453
- **Spread:** 
- **Upper Limit:** 1.525
- **Value:** 1.489
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 172
- **Spread:** 
- **Upper Limit:** 246
- **Value:** 209
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 302
- **Spread:** 
- **Upper Limit:** 376
- **Value:** 339
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 292
- **Spread:** 
- **Upper Limit:** 367
- **Value:** 329
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 311
- **Spread:** 
- **Upper Limit:** 386
- **Value:** 348
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 296
- **Spread:** 
- **Upper Limit:** 370
- **Value:** 333
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 275
- **Spread:** 
- **Upper Limit:** 349
- **Value:** 312
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 280
- **Spread:** 
- **Upper Limit:** 355
- **Value:** 317
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 201
- **Spread:** 
- **Upper Limit:** 274
- **Value:** 238
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 65
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 62
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 65
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 66
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 60
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 56
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 93
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 85
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 84
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 86
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 83
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 131
- **Spread:** 
- **Upper Limit:** 278
- **Value:** 204
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 320
- **Spread:** 
- **Upper Limit:** 467
- **Value:** 393
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 244
- **Spread:** 
- **Upper Limit:** 397
- **Value:** 320
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 313
- **Spread:** 
- **Upper Limit:** 461
- **Value:** 387
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 274
- **Spread:** 
- **Upper Limit:** 421
- **Value:** 347
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 276
- **Spread:** 
- **Upper Limit:** 420
- **Value:** 348
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 261
- **Spread:** 
- **Upper Limit:** 409
- **Value:** 335
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 160
- **Spread:** 
- **Upper Limit:** 305
- **Value:** 233
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 87
- **Spread:** 
- **Upper Limit:** 152
- **Value:** 120
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 151
- **Spread:** 
- **Upper Limit:** 216
- **Value:** 183
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 117
- **Spread:** 
- **Upper Limit:** 184
- **Value:** 150
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 121
- **Spread:** 
- **Upper Limit:** 186
- **Value:** 154
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 130
- **Spread:** 
- **Upper Limit:** 195
- **Value:** 163
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 98
- **Spread:** 
- **Upper Limit:** 162
- **Value:** 130
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 71
- **Spread:** 
- **Upper Limit:** 137
- **Value:** 104
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 90
- **Spread:** 
- **Upper Limit:** 155
- **Value:** 122
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 257
- **Spread:** 
- **Upper Limit:** 342
- **Value:** 300
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 402
- **Spread:** 
- **Upper Limit:** 487
- **Value:** 444
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 370
- **Spread:** 
- **Upper Limit:** 458
- **Value:** 414
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 361
- **Spread:** 
- **Upper Limit:** 446
- **Value:** 403
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 345
- **Spread:** 
- **Upper Limit:** 430
- **Value:** 388
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 321
- **Spread:** 
- **Upper Limit:** 404
- **Value:** 363
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 289
- **Spread:** 
- **Upper Limit:** 375
- **Value:** 332
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 267
- **Spread:** 
- **Upper Limit:** 351
- **Value:** 309
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 46
- **Spread:** 
- **Upper Limit:** 171
- **Value:** 109
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 123
- **Spread:** 
- **Upper Limit:** 246
- **Value:** 185
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 119
- **Spread:** 
- **Upper Limit:** 247
- **Value:** 183
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 153
- **Spread:** 
- **Upper Limit:** 278
- **Value:** 215
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 141
- **Spread:** 
- **Upper Limit:** 265
- **Value:** 203
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 89
- **Spread:** 
- **Upper Limit:** 212
- **Value:** 151
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 67
- **Spread:** 
- **Upper Limit:** 191
- **Value:** 129
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 45
- **Spread:** 
- **Upper Limit:** 168
- **Value:** 106
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 149
- **Spread:** 
- **Upper Limit:** 297
- **Value:** 223
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 357
- **Spread:** 
- **Upper Limit:** 503
- **Value:** 430
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 366
- **Spread:** 
- **Upper Limit:** 516
- **Value:** 441
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 335
- **Spread:** 
- **Upper Limit:** 484
- **Value:** 409
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 294
- **Spread:** 
- **Upper Limit:** 441
- **Value:** 368
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 298
- **Spread:** 
- **Upper Limit:** 444
- **Value:** 371
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 303
- **Spread:** 
- **Upper Limit:** 452
- **Value:** 377
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 168
- **Spread:** 
- **Upper Limit:** 314
- **Value:** 241
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 53
- **Spread:** 
- **Upper Limit:** 145
- **Value:** 99
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 151
- **Spread:** 
- **Upper Limit:** 241
- **Value:** 196
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 115
- **Spread:** 
- **Upper Limit:** 209
- **Value:** 162
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 73
- **Spread:** 
- **Upper Limit:** 163
- **Value:** 118
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 87
- **Spread:** 
- **Upper Limit:** 179
- **Value:** 133
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 65
- **Spread:** 
- **Upper Limit:** 155
- **Value:** 110
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 28
- **Spread:** 
- **Upper Limit:** 119
- **Value:** 73
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 85
- **Spread:** 
- **Upper Limit:** 174
- **Value:** 130
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.5
- **Spread:** 
- **Upper Limit:** 14.8
- **Value:** 7.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 18.1
- **Spread:** 
- **Upper Limit:** 32.4
- **Value:** 25.2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 9.4
- **Spread:** 
- **Upper Limit:** 23.9
- **Value:** 16.6
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 5.2
- **Spread:** 
- **Upper Limit:** 19.5
- **Value:** 12.4
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 10.9
- **Spread:** 
- **Upper Limit:** 25.1
- **Value:** 18.0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 6.7
- **Spread:** 
- **Upper Limit:** 20.8
- **Value:** 13.8
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 1.5
- **Spread:** 
- **Upper Limit:** 15.7
- **Value:** 8.6
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 4.5
- **Spread:** 
- **Upper Limit:** 18.7
- **Value:** 11.6
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 23.0
- **Spread:** 
- **Upper Limit:** 39.0
- **Value:** 31.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 50.9
- **Spread:** 
- **Upper Limit:** 66.7
- **Value:** 58.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 46.9
- **Spread:** 
- **Upper Limit:** 63.1
- **Value:** 55.0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 38.8
- **Spread:** 
- **Upper Limit:** 54.6
- **Value:** 46.7
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 44.1
- **Spread:** 
- **Upper Limit:** 60.0
- **Value:** 52.1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 41.7
- **Spread:** 
- **Upper Limit:** 57.4
- **Value:** 49.6
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 35.3
- **Spread:** 
- **Upper Limit:** 51.1
- **Value:** 43.2
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 30.0
- **Spread:** 
- **Upper Limit:** 45.8
- **Value:** 37.9
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.6
- **Spread:** 
- **Upper Limit:** 18.7
- **Value:** 11.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 25.4
- **Spread:** 
- **Upper Limit:** 39.5
- **Value:** 32.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 18.0
- **Spread:** 
- **Upper Limit:** 32.1
- **Value:** 25.0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 12.0
- **Spread:** 
- **Upper Limit:** 26.0
- **Value:** 19.0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 18.7
- **Spread:** 
- **Upper Limit:** 32.5
- **Value:** 25.6
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 13.0
- **Spread:** 
- **Upper Limit:** 26.8
- **Value:** 19.9
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 9.6
- **Spread:** 
- **Upper Limit:** 23.4
- **Value:** 16.5
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 26.8
- **Spread:** 
- **Upper Limit:** 43.2
- **Value:** 35.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 53.1
- **Spread:** 
- **Upper Limit:** 69.8
- **Value:** 61.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 47.8
- **Spread:** 
- **Upper Limit:** 64.3
- **Value:** 56.1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 43.3
- **Spread:** 
- **Upper Limit:** 59.7
- **Value:** 51.5
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 45.6
- **Spread:** 
- **Upper Limit:** 61.7
- **Value:** 53.7
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 45.8
- **Spread:** 
- **Upper Limit:** 61.8
- **Value:** 53.8
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 40.3
- **Spread:** 
- **Upper Limit:** 56.4
- **Value:** 48.3
- **Comment:** 
- **Group ID:** OG007
- **Lower Limit:** 22.2
- **Spread:** 
- **Upper Limit:** 38.4
- **Value:** 30.3
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** FEV1 AUC 0-12
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** MITT
**Reporting Status:** POSTED
**Time Frame:** Day 7
**Title:** FEV1 AUC 0-12 on Day 7
**Type:** PRIMARY
**Unit of Measure:** Liters
##### Group
**Description:** 18 μg
**ID:** OG000
**Title:** GP MDI 18 μg (PT001)
##### Group
**Description:** 18/9.6 μg
**ID:** OG001
**Title:** GFF MDI 18/9.6 μg (PT003)
##### Group
**Description:** 9/9.6 μg
**ID:** OG002
**Title:** GFF/MDI 9/9.6 μg
##### Group
**Description:** 4.6/9.6 μg
**ID:** OG003
**Title:** GFF MDI BID 4.6/9.6 μg
##### Group
**Description:** 2.4/9.6 μg
**ID:** OG004
**Title:** GFF MDI 2.4/9.6 μg (PT003)
##### Group
**Description:** 1.2/9.6 μg
**ID:** OG005
**Title:** GFF MDI 1.2/9.6 μg (PT003)
##### Group
**Description:** 9.6 μg
**ID:** OG006
**Title:** FF MDI 9.6 μg
##### Group
**Description:** 18 μg QD
**ID:** OG007
**Title:** Spiriva 18 μg QD
#### Outcome Measure 2
**Description:** Peak change from Baseline in FEV1 on Treatment
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** MITT
**Reporting Status:** POSTED
**Time Frame:** Day 1
**Title:** Peak Change From Baseline in FEV1 on Treatment Day 1
**Type:** SECONDARY
**Unit of Measure:** Milliliters
##### Group
**Description:** BID 18 μg
**ID:** OG000
**Title:** GP MDI BID 18 μg
##### Group
**Description:** BID 18/9.6 μg
**ID:** OG001
**Title:** GFF MDI BID 18/9.6 μg
##### Group
**Description:** BID 9/9.6 μg
**ID:** OG002
**Title:** GFF/MDI BID 9/9.6 μg
##### Group
**Description:** 4.6/9.6 μg
**ID:** OG003
**Title:** GFF MDI BID 4.6/9.6 μg
##### Group
**Description:** BID 2.4/9.6 μg
**ID:** OG004
**Title:** GFF MDI BID 2.4/9.6 μg
##### Group
**Description:** BID 1.2/9.6 μg
**ID:** OG005
**Title:** GFF MDI BID 1.2/9.6 μg
##### Group
**Description:** BID 9.6 μg
**ID:** OG006
**Title:** FF MDI BID 9.6 μg
##### Group
**Description:** 18 μg QD
**ID:** OG007
**Title:** Spiriva 18 μg QD
#### Outcome Measure 3
**Description:** Time to onset of action (\>10% improvement in FEV1)
**Parameter Type:** NUMBER
**Population Description:** MITT
**Reporting Status:** POSTED
**Time Frame:** Day 1
**Title:** Time to Onset of Action (>10% Improvement in FEV1) on Day 1
**Type:** SECONDARY
**Unit of Measure:** Percentage
##### Group
**Description:** BID 18 μg
**ID:** OG000
**Title:** GP MDI BID 18 μg
##### Group
**Description:** BID 18/9.6 μg
**ID:** OG001
**Title:** GFF MDI BID 18/9.6 μg
##### Group
**Description:** BID 9/9.6 μg
**ID:** OG002
**Title:** GFF/MDI BID 9/9.6 μg
##### Group
**Description:** 4.6/9.6 μg
**ID:** OG003
**Title:** GFF MDI BID 4.6/9.6 μg
##### Group
**Description:** BID 2.4/9.6 μg
**ID:** OG004
**Title:** GFF MDI BID 2.4/9.6 μg
##### Group
**Description:** BID 1.2/9.6 μg
**ID:** OG005
**Title:** GFF MDI BID 1.2/9.6 μg
##### Group
**Description:** BID 9.6 μg
**ID:** OG006
**Title:** FF MDI BID 9.6 μg
##### Group
**Description:** 18 μg QD
**ID:** OG007
**Title:** Spiriva 18 μg QD
#### Outcome Measure 4
**Description:** Proportion of subjects achieving \>=12% improvement in FEV1
**Parameter Type:** NUMBER
**Population Description:** MITT
**Reporting Status:** POSTED
**Time Frame:** Day 1
**Title:** Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1
**Type:** SECONDARY
**Unit of Measure:** Percentage
##### Group
**Description:** BID 18 μg
**ID:** OG000
**Title:** GP MDI BID 18 μg
##### Group
**Description:** BID 18/9.6 μg
**ID:** OG001
**Title:** GFF MDI BID 18/9.6 μg
##### Group
**Description:** BID 9/9.6 μg
**ID:** OG002
**Title:** GFF/MDI BID 9/9.6 μg
##### Group
**Description:** 4.6/9.6 μg
**ID:** OG003
**Title:** GFF MDI BID 4.6/9.6 μg
##### Group
**Description:** BID 2.4/9.6 μg
**ID:** OG004
**Title:** GFF MDI BID 2.4/9.6 μg
##### Group
**Description:** BID 1.2/9.6 μg
**ID:** OG005
**Title:** GFF MDI BID 1.2/9.6 μg
##### Group
**Description:** BID 9.6 μg
**ID:** OG006
**Title:** FF MDI BID 9.6 μg
##### Group
**Description:** 18 μg
**ID:** OG007
**Title:** GP MDI 18 μg (PT001)
#### Outcome Measure 5
**Description:** Peak change from baseline in Inspiratory Capacity
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** MITT
**Reporting Status:** POSTED
**Time Frame:** Day 1
**Title:** Peak Change From Baseline in Inspiratory Capacity on Day 1
**Type:** SECONDARY
**Unit of Measure:** Milliliters
##### Group
**Description:** BID 18 μg
**ID:** OG000
**Title:** GP MDI BID 18 μg
##### Group
**Description:** BID 18/9.6 μg
**ID:** OG001
**Title:** GFF MDI BID 18/9.6 μg
##### Group
**Description:** BID 9/9.6 μg
**ID:** OG002
**Title:** GFF/MDI BID 9/9.6 μg
##### Group
**Description:** 4.6/9.6 μg
**ID:** OG003
**Title:** GFF MDI BID 4.6/9.6 μg
##### Group
**Description:** BID 2.4/9.6 μg
**ID:** OG004
**Title:** GFF MDI BID 2.4/9.6 μg
##### Group
**Description:** BID 1.2/9.6 μg
**ID:** OG005
**Title:** GFF MDI BID 1.2/9.6 μg
##### Group
**Description:** BID 9.6 μg
**ID:** OG006
**Title:** FF MDI BID 9.6 μg
##### Group
**Description:** 18 μg QD
**ID:** OG007
**Title:** Spiriva 18 μg QD
#### Outcome Measure 6
**Description:** Change from baseline in morning pre-dose trough FEV1
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** MITT
**Reporting Status:** POSTED
**Time Frame:** Day 7
**Title:** Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7
**Type:** SECONDARY
**Unit of Measure:** Milliliters
##### Group
**Description:** BID 18 μg
**ID:** OG000
**Title:** GP MDI BID 18 μg
##### Group
**Description:** BID 18/9.6 μg
**ID:** OG001
**Title:** GFF MDI BID 18/9.6 μg
##### Group
**Description:** BID 9/9.6 μg
**ID:** OG002
**Title:** GFF/MDI BID 9/9.6 μg
##### Group
**Description:** 4.6/9.6 μg
**ID:** OG003
**Title:** GFF MDI BID 4.6/9.6 μg
##### Group
**Description:** BID 2.4/9.6 μg
**ID:** OG004
**Title:** GFF MDI BID 2.4/9.6 μg
##### Group
**Description:** BID 1.2/9.6 μg
**ID:** OG005
**Title:** GFF MDI BID 1.2/9.6 μg
##### Group
**Description:** BID 9.6 μg
**ID:** OG006
**Title:** FF MDI BID 9.6 μg
##### Group
**Description:** 18 μg QD
**ID:** OG007
**Title:** Spiriva 18 μg QD
#### Outcome Measure 7
**Description:** Peak change from baseline in FEV1 Day 7
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** MITT
**Reporting Status:** POSTED
**Time Frame:** Day 7
**Title:** Peak Change From Baseline in FEV1 on Day 7
**Type:** SECONDARY
**Unit of Measure:** Millliters
##### Group
**Description:** BID 18 μg
**ID:** OG000
**Title:** GP MDI BID 18 μg
##### Group
**Description:** BID 18/9.6 μg
**ID:** OG001
**Title:** GFF MDI BID 18/9.6 μg
##### Group
**Description:** BID 9/9.6 μg
**ID:** OG002
**Title:** GFF/MDI BID 9/9.6 μg
##### Group
**Description:** 4.6/9.6 μg
**ID:** OG003
**Title:** GFF MDI BID 4.6/9.6 μg
##### Group
**Description:** BID 2.4/9.6 μg
**ID:** OG004
**Title:** GFF MDI BID 2.4/9.6 μg
##### Group
**Description:** BID 1.2/9.6 μg
**ID:** OG005
**Title:** GFF MDI BID 1.2/9.6 μg
##### Group
**Description:** BID 9.6 μg
**ID:** OG006
**Title:** FF MDI BID 9.6 μg
##### Group
**Description:** 18 μg QD
**ID:** OG007
**Title:** Spiriva 18 μg QD
#### Outcome Measure 8
**Description:** Change from baseline in morning pre-dose trough IC
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** MITT
**Reporting Status:** POSTED
**Time Frame:** Day 7
**Title:** Change From Baseline in Morning Pre-dose Trough IC on Day 7
**Type:** SECONDARY
**Unit of Measure:** Millliters
##### Group
**Description:** BID 18 μg
**ID:** OG000
**Title:** GP MDI BID 18 μg
##### Group
**Description:** BID 18/9.6 μg
**ID:** OG001
**Title:** GFF MDI BID 18/9.6 μg
##### Group
**Description:** BID 9/9.6 μg
**ID:** OG002
**Title:** GFF/MDI BID 9/9.6 μg
##### Group
**Description:** 4.6/9.6 μg
**ID:** OG003
**Title:** GFF MDI BID 4.6/9.6 μg
##### Group
**Description:** BID 2.4/9.6 μg
**ID:** OG004
**Title:** GFF MDI BID 2.4/9.6 μg
##### Group
**Description:** BID 1.2/9.6 μg
**ID:** OG005
**Title:** GFF MDI BID 1.2/9.6 μg
##### Group
**Description:** BID 9.6 μg
**ID:** OG006
**Title:** FF MDI BID 9.6 μg
##### Group
**Description:** 18 μg QD
**ID:** OG007
**Title:** Spiriva 18 μg QD
#### Outcome Measure 9
**Description:** Peak change from baseline IC
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** MITT
**Reporting Status:** POSTED
**Time Frame:** Day 7
**Title:** Peak Change From Baseline IC on Day 7
**Type:** SECONDARY
**Unit of Measure:** Millliters
##### Group
**Description:** BID 18 μg
**ID:** OG000
**Title:** GP MDI BID 18 μg
##### Group
**Description:** BID 18/9.6 μg
**ID:** OG001
**Title:** GFF MDI BID 18/9.6 μg
##### Group
**Description:** BID 9/9.6 μg
**ID:** OG002
**Title:** GFF/MDI BID 9/9.6 μg
##### Group
**Description:** 4.6/9.6 μg
**ID:** OG003
**Title:** GFF MDI BID 4.6/9.6 μg
##### Group
**Description:** BID 2.4/9.6 μg
**ID:** OG004
**Title:** GFF MDI BID 2.4/9.6 μg
##### Group
**Description:** BID 1.2/9.6 μg
**ID:** OG005
**Title:** GFF MDI BID 1.2/9.6 μg
##### Group
**Description:** BID 9.6 μg
**ID:** OG006
**Title:** FF MDI BID 9.6 μg
##### Group
**Description:** 18 μg QD
**ID:** OG007
**Title:** Spiriva 18 μg QD
#### Outcome Measure 10
**Description:** Change from baseline at evening 12-hour post-dose trough FEV1
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** MITT
**Reporting Status:** POSTED
**Time Frame:** Day 7
**Title:** Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7
**Type:** SECONDARY
**Unit of Measure:** Millliters
##### Group
**Description:** BID 18 μg
**ID:** OG000
**Title:** GP MDI BID 18 μg
##### Group
**Description:** BID 18/9.6 μg
**ID:** OG001
**Title:** GFF MDI BID 18/9.6 μg
##### Group
**Description:** BID 9/9.6 μg
**ID:** OG002
**Title:** GFF/MDI BID 9/9.6 μg
##### Group
**Description:** 4.6/9.6 μg
**ID:** OG003
**Title:** GFF MDI BID 4.6/9.6 μg
##### Group
**Description:** BID 2.4/9.6 μg
**ID:** OG004
**Title:** GFF MDI BID 2.4/9.6 μg
##### Group
**Description:** BID 1.2/9.6 μg
**ID:** OG005
**Title:** GFF MDI BID 1.2/9.6 μg
##### Group
**Description:** BID 9.6 μg
**ID:** OG006
**Title:** FF MDI BID 9.6 μg
##### Group
**Description:** 18 μg QD
**ID:** OG007
**Title:** Spiriva 18 μg QD
#### Outcome Measure 11
**Description:** Change from baseline in mean morning pre-dose daily peak flow readings
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** MITT
**Reporting Status:** POSTED
**Time Frame:** Day 7
**Title:** Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7
**Type:** SECONDARY
**Unit of Measure:** L/min
##### Group
**Description:** 18 μg BID
**ID:** OG000
**Title:** GP MDI 18 μg BID
##### Group
**Description:** 18/9.6 μg BID
**ID:** OG001
**Title:** GFF MDI 18/9.6 μg BID
##### Group
**Description:** 9/9.6 μg BID
**ID:** OG002
**Title:** GFF/MDI 9/9.6 μg BID
##### Group
**Description:** 4.6/9.6 μg
**ID:** OG003
**Title:** GFF MDI BID 4.6/9.6 μg
##### Group
**Description:** 2.4/9.6 μg BID
**ID:** OG004
**Title:** GFF MDI 2.4/9.6 μg BID
##### Group
**Description:** 1.2/9.6 μg BID
**ID:** OG005
**Title:** GFF MDI 1.2/9.6 μg BID
##### Group
**Description:** 9.6 μg BID
**ID:** OG006
**Title:** FF MDI 9.6 μg BID
##### Group
**Description:** 18 μg QD
**ID:** OG007
**Title:** Spiriva 18 μg QD
#### Outcome Measure 12
**Description:** Change from baseline in mean morning post-dose daily peak flow readings on
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** MITT
**Reporting Status:** POSTED
**Time Frame:** Day 7
**Title:** Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7
**Type:** SECONDARY
**Unit of Measure:** L/min
##### Group
**Description:** 18 μg BID
**ID:** OG000
**Title:** GP MDI 18 μg BID
##### Group
**Description:** BID 18/9.6 μg
**ID:** OG001
**Title:** GFF MDI BID 18/9.6 μg
##### Group
**Description:** BID 9/9.6 μg
**ID:** OG002
**Title:** GFF/MDI BID 9/9.6 μg
##### Group
**Description:** 4.6/9.6 μg
**ID:** OG003
**Title:** GFF MDI BID 4.6/9.6 μg
##### Group
**Description:** BID 2.4/9.6 μg
**ID:** OG004
**Title:** GFF MDI BID 2.4/9.6 μg
##### Group
**Description:** 1.2/9.6 μg BID
**ID:** OG005
**Title:** GFF MDI 1.2/9.6 μg BID
##### Group
**Description:** 9.6 μg BID
**ID:** OG006
**Title:** FF MDI 9.6 μg BID
##### Group
**Description:** 18 μg QD
**ID:** OG007
**Title:** Spiriva 18 μg QD
#### Outcome Measure 13
**Description:** Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** MITT
**Reporting Status:** POSTED
**Time Frame:** Day 7
**Title:** Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7
**Type:** SECONDARY
**Unit of Measure:** L/min
##### Group
**Description:** 18 μg BID
**ID:** OG000
**Title:** GP MDI 18 μg BID
##### Group
**Description:** 18/9.6 μg BID
**ID:** OG001
**Title:** GFF MDI 18/9.6 μg BID
##### Group
**Description:** 9/9.6 μg BID
**ID:** OG002
**Title:** GFF/MDI 9/9.6 μg BID
##### Group
**Description:** 4.6/9.6 μg BID
**ID:** OG003
**Title:** GFF MDI 4.6/9.6 μg BID
##### Group
**Description:** 2.4/9.6 μg BID
**ID:** OG004
**Title:** GFF MDI 2.4/9.6 μg BID
##### Group
**Description:** 1.2/9.6 μg BID
**ID:** OG005
**Title:** GFF MDI 1.2/9.6 μg BID
##### Group
**Description:** 9.6 μg BID
**ID:** OG006
**Title:** FF MDI 9.6 μg BID
##### Group
**Description:** 18 μg QD
**ID:** OG007
**Title:** Spiriva18 μg QD
#### Outcome Measure 14
**Description:** Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** MITT
**Reporting Status:** POSTED
**Time Frame:** Day 7
**Title:** Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7
**Type:** SECONDARY
**Unit of Measure:** L/min
##### Group
**Description:** 18 μg BID
**ID:** OG000
**Title:** GP MDI 18 μg BID
##### Group
**Description:** 18/9.6 μg BID
**ID:** OG001
**Title:** GFF MDI 18/9.6 μg BID
##### Group
**Description:** 9/9.6 μg BID
**ID:** OG002
**Title:** GFF/MDI 9/9.6 μg BID
##### Group
**Description:** 4.6/9.6 μg BID
**ID:** OG003
**Title:** GFF MDI BID 4.6/9.6 μg BID
##### Group
**Description:** 2.4/9.6 μg BID
**ID:** OG004
**Title:** GFF MDI 2.4/9.6 μg BID
##### Group
**Description:** 1.2/9.6 μg BID
**ID:** OG005
**Title:** GFF MDI 1.2/9.6 μg BID
##### Group
**Description:** 9.6 μg BID
**ID:** OG006
**Title:** FF MDI 9.6 μg BID
##### Group
**Description:** 18 μg QD
**ID:** OG007
**Title:** Spiriva 18 μg QD
### Participant Flow Module
#### Group
**ID:** FG000
**Title:** All Subjects
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Protocol-specified criteria
###### Reason
**Group ID:** FG000
**Number of Subjects:** 9
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 14
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 159
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 120
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 39
**Pre-Assignment Details:** Study was a chronic dosing (7 days), 4-period, 8-treatment, Incomplete Block, Cross-Over.
**Recruitment Details:** The study was conducted at 20 sites in the US from May 2012 until September 2012. The entire study was scheduled to take a maximum of 19 weeks for each individual subject.
**Has Results:** True