## Protocol Section
### Identification Module
**NCT ID:** NCT02251379

**Acronym:** ECATCh

**Brief Title:** Environmental Control as Add-on Therapy in Childhood Asthma

**Official Title:** Environmental Control as Add-on Therapy in Childhood Asthma

#### Organization Study ID Info
**ID:** NA_00093323
#### Organization
**Class:** OTHER
**Full Name:** Johns Hopkins University
### Status Module
#### Completion Date
**Date:** 2018-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-11-20

**Type:** ACTUAL

**Last Update Submit Date:** 2019-11-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-11

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-11-04

**Type:** ACTUAL

**Results First Submit Date:** 2019-10-15

**Results First Submit QC Date:** 2019-10-15

#### Start Date
**Date:** 2014-10-01

**Type:** ACTUAL

**Status Verified Date:** 2019-11

#### Study First Post Date
**Date:** 2014-09-29
**Type:** ESTIMATED
**Study First Submit Date:** 2014-09-22
**Study First Submit QC Date:** 2014-09-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Johns Hopkins University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study evaluates the effects of adding on an environmental home intervention to standard asthma medication management on controller medication requirements among children and adolescents with asthma. The investigators hypothesize that the addition of an individually-tailored, multi-faceted Environmental Control Strategy (ECS) to guidelines-based controller medication will result in less controller medication requirement and allergic inflammation than controller medication alone among urban asthmatic children.

**Detailed Description:** The study is a parallel arm study of an individually tailored, multi-faceted ECS plus controller medication titration versus controller medication titration alone. After a 4-week run-in period to stabilize the asthma, the investigators will randomize 200 Baltimore children with persistent asthma and a recent exacerbation in a 1:1 ratio to the two arms and follow the children for six months. There will be five clinic visits and three home visits over this time period for clinical and home assessments, respectively. There will be up to four environmental intervention visits for participants randomized to the environmental control plus controller medication group. The environmental modules include mouse, cockroach, furry pets, dust mites, and smoking. Air purifiers and laundered bedding are also included in this arm. Participants randomized to the controller medication group have the option of having one home visit after completing the study at which the participants will receive home intervention services that the environmental control plus controller medication group received. Participants will have repeated assessment of: controller medication requirements; secondary clinical, physiologic, and inflammatory outcomes; and particulate matter (PM), air nicotine, and allergen levels.

### Conditions Module

**Conditions:**

- Asthma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 155

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

**Intervention Names:**

- Drug: Flovent Diskus

- Other: Home Environmental Intervention

- Drug: Advair Diskus

**Label:** ECS + Medication Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

**Intervention Names:**

- Drug: Flovent Diskus

- Drug: Advair Diskus

**Label:** Medication Group Alone

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ECS + Medication Group

- Medication Group Alone

**Description:** Inhaled corticosteroids

**Name:** Flovent Diskus

**Other Names:**

- Flovent Diskus, 50 mcg, 100mcg, 250 mcg

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- ECS + Medication Group

**Description:** Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding

**Name:** Home Environmental Intervention

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- ECS + Medication Group

- Medication Group Alone

**Description:** inhaled corticosteroids + long-acting beta agonist

**Name:** Advair Diskus

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The controller medication treatment step that was assigned at the visit, which is based on the current controller medication treatment step and the current level of asthma control. The range is from 0-6, with 0 indicating no controller medication and 6 indicating high dose inhaled corticosteroids plus long-acting beta agonist.

**Measure:** The Medication Treatment Step Assigned

**Time Frame:** 6 month clinic visit

#### Secondary Outcomes

**Description:** micrograms of inhaled corticosteroids (daily)

**Measure:** Daily Inhaled Corticosteroid Dose

**Time Frame:** 6 months

**Description:** Exhaled nitric oxide in parts per billion.

**Measure:** Exhaled Nitric Oxide

**Time Frame:** 6 months

**Description:** Number of asthma symptom days in the past two weeks will be a measure of asthma control.

**Measure:** Number of Asthma Symptom Days

**Time Frame:** 6 months

**Description:** Asthma exacerbations will be assessed by number of acute visits to the emergency department (ED), hospitalizations and urgent doctor visits.

**Measure:** Number of Asthma Exacerbations

**Time Frame:** 6 months

**Description:** Forced expiratory volume at one second/forced vital capacity (FEV1/FVC) will be evaluated as a continuous variable. This is a ratio without any units.

**Measure:** FEV1/FVC

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Have physician-diagnosed asthma at least 1 year prior to the baseline visit, or asthma symptoms for at least 1 year
* Meet criteria for current persistent asthma defined as either:

  1. On a long-term controller medication for asthma, or
  2. Meet National Asthma Education and Prevention Program (NAEPP) guideline requirements for persistent disease:(46)
* Asthma symptoms 3 or more days per week over the past 2 weeks or
* Nocturnal asthma symptoms at least 3 times in the past month
* Have evidence of uncontrolled disease as defined by at least one of the following:

  1. One asthma-related unscheduled visit to an emergency department (ED), clinic or urgent care facility in the previous 12 mo
  2. One asthma-related overnight hospitalization in the previous 12 mo
  3. One or more bursts of oral corticosteroids in the previous 12 mo
* Reside within a geographic area of the study site so that home visits are feasible.
* Have no plans to move within the upcoming 6 months
* Have insurance to cover prescription medications.
* Have a positive skin test (net wheal ≥2mm) to cat, dog, mouse, cockroach, or dust mites or have a positive cat, dog, mouse, German cockroach, or D. farinae-specific immunoglobulin E (IgE) test, as quantified using the ImmunoCAP system (≥0.35 kU/L)

Exclusion Criteria:

* Lung disease, other than asthma, that requires daily medication
* Cardiovascular disease that requires daily medication, excluding hypertension
* Taking a beta-blocker
* Allergy to dairy
* On Xolair \< 5 months
* On immunotherapy and has not reached maintenance dose
* Sleeping in another home 4 or more nights/week
* Active smoker defined as a positive urine screen for high levels of urine cotinine
* Unable to access areas of home necessary to conduct extermination

**Maximum Age:** 17 Years

**Minimum Age:** 5 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Baltimore

**Country:** United States

**Facility:** Johns Hopkins University

**State:** Maryland

**Zip:** 21287

#### Overall Officials

**Official 1:**

**Affiliation:** Johns Hopkins University

**Name:** Elizabeth C Matsui, MD MHS

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Johns Hopkins University

**Name:** Meredith McCormack, MD MHS

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Johns Hopkins University

**Name:** Corinne Keet, MD PHD

**Role:** PRINCIPAL_INVESTIGATOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2016-10-03

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 1248763

- Type Abbrev: Prot_SAP

- Upload Date: 2019-10-14T10:42

## 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: 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: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000013566

- Term: Sympathomimetics

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000003879

- Term: Dermatologic Agents

- ID: D000018926

- Term: Anti-Allergic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: AAll

- Name: Anti-Allergic Agents

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M250

- Name: Fluticasone

- Relevance: HIGH

- As Found: Coronary Revascularization

- ID: M353494

- Name: Xhance

- Relevance: HIGH

- As Found: Coronary Revascularization

- ID: M249

- Name: Fluticasone-Salmeterol Drug Combination

- Relevance: HIGH

- As Found: E. coli

- ID: M251

- Name: Salmeterol Xinafoate

- Relevance: LOW

- As Found: Unknown

- 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: 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

- ID: M16345

- Name: Sympathomimetics

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7074

- Name: Dermatologic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20962

- Name: Anti-Allergic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068298

- Term: Fluticasone

- ID: C000716389

- Term: Xhance

- ID: D000068297

- Term: Fluticasone-Salmeterol Drug Combination

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Hospitalizations, including asthma-related hospitalizations, were considered serious adverse events. Participants were asked at each clinic visit about adverse events.

#### Event Groups

**Group ID:** EG000

**Title:** ECS + Medication Group

**Deaths Num At Risk:** 77

**Description:** The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding

Advair Diskus: inhaled corticosteroids + long-acting beta agonist

**ID:** EG000

**Other Num at Risk:** 77

**Serious Number Affected:** 2

**Serious Number At Risk:** 77

**Title:** ECS + Medication Group

**Group ID:** EG001

**Title:** Medication Group Alone

**Deaths Num At Risk:** 78

**Description:** inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Advair Diskus: inhaled corticosteroids + long-acting beta agonist

**ID:** EG001

**Other Num at Risk:** 78

**Serious Number Affected:** 10

**Serious Number At Risk:** 78

**Title:** Medication Group Alone

**Frequency Threshold:** 5

#### Serious Events

**Term:** asthma hospitalization

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 77

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 8

**Num At Risk:** 78

**Num Events:** 11

**Term:** hospitalization

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 77

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Num Events:** 1

**Term:** hospitalization

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 77

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 78

**Num Events:** 1

**Time Frame:** During the enrollment period, approximately 7 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 77

**Group ID:** BG001

**Value:** 78

**Group ID:** BG002

**Value:** 155

**Units:** Participants

### Group

**ID:** BG000

**Title:** ECS + Medication Group

**Description:** The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding

Advair Diskus: inhaled corticosteroids + long-acting beta agonist

### Group

**ID:** BG001

**Title:** Medication Group Alone

**Description:** inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Advair Diskus: inhaled corticosteroids + long-acting beta agonist

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 3.3

**Value:** 10.1

#### Measurement

**Group ID:** BG001

**Spread:** 3.3

**Value:** 10.1

#### Measurement

**Group ID:** BG002

**Spread:** 3.3

**Value:** 10.1

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 31

#### Measurement

**Group ID:** BG001

**Value:** 30

#### Measurement

**Group ID:** BG002

**Value:** 61

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 46

#### Measurement

**Group ID:** BG001

**Value:** 48

#### Measurement

**Group ID:** BG002

**Value:** 94

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 75

#### Measurement

**Group ID:** BG001

**Value:** 76

#### Measurement

**Group ID:** BG002

**Value:** 151

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

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

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

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

#### Measurement

**Group ID:** BG000

**Value:** 72

#### Measurement

**Group ID:** BG001

**Value:** 67

#### Measurement

**Group ID:** BG002

**Value:** 139

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 12

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 77

#### Measurement

**Group ID:** BG001

**Value:** 78

#### Measurement

**Group ID:** BG002

**Value:** 155

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.56

**Value:** 4.34

#### Measurement

**Group ID:** BG001

**Spread:** 1.57

**Value:** 4.56

#### Measurement

**Group ID:** BG002

**Spread:** 1.56

**Value:** 4.45

**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:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
### Measure 6
**Description:** The controller medication treatment step that was assigned at the visit, which is based on the current controller medication treatment step and the current level of asthma control. The range is from 0-6, with 0 indicating no controller medication and 6 indicating high dose inhaled corticosteroids plus long-acting beta agonist.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** The treatment step assigned
**Unit of Measure:** score on a scale
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** ckeet1@jhmi.edu
**Organization:** Johns Hopkins University
**Phone:** 410-955-5883
**Title:** Corinne Keet
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.91
- **Upper Limit:** 
- **Value:** 4.03
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.87
- **Upper Limit:** 
- **Value:** 4.05
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 347.8
- **Upper Limit:** 
- **Value:** 557.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 401.7
- **Upper Limit:** 
- **Value:** 527.7
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 10
- **Spread:** 
- **Upper Limit:** 38
- **Value:** 20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 8
- **Spread:** 
- **Upper Limit:** 52
- **Value:** 20
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.2
- **Upper Limit:** 
- **Value:** 2.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.6
- **Upper Limit:** 
- **Value:** 2.7
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 35
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.1
- **Upper Limit:** 
- **Value:** 79.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.8
- **Upper Limit:** 
- **Value:** 80.8
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The controller medication treatment step that was assigned at the visit, which is based on the current controller medication treatment step and the current level of asthma control. The range is from 0-6, with 0 indicating no controller medication and 6 indicating high dose inhaled corticosteroids plus long-acting beta agonist.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** participants completing the final 6 month follow-up visit
**Reporting Status:** POSTED
**Time Frame:** 6 month clinic visit
**Title:** The Medication Treatment Step Assigned
**Type:** PRIMARY
**Unit of Measure:** score on a scale
##### Group
**Description:** The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding

Advair Diskus: inhaled corticosteroids + long-acting beta agonist
**ID:** OG000
**Title:** ECS + Medication Group
##### Group
**Description:** inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Advair Diskus: inhaled corticosteroids + long-acting beta agonist
**ID:** OG001
**Title:** Medication Group Alone
#### Outcome Measure 2
**Description:** micrograms of inhaled corticosteroids (daily)
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** participants who completed the final follow-up visit at 6 months
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Daily Inhaled Corticosteroid Dose
**Type:** SECONDARY
**Unit of Measure:** micrograms/day
##### Group
**Description:** The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding

Advair Diskus: inhaled corticosteroids + long-acting beta agonist
**ID:** OG000
**Title:** ECS + Medication Group
##### Group
**Description:** inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Advair Diskus: inhaled corticosteroids + long-acting beta agonist
**ID:** OG001
**Title:** Medication Group Alone
#### Outcome Measure 3
**Description:** Exhaled nitric oxide in parts per billion.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** participants completing the final follow-up visit at 6 months with valid exhaled nitric oxide measurement. Not all participants had valid measures.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Exhaled Nitric Oxide
**Type:** SECONDARY
**Unit of Measure:** parts per billion
##### Group
**Description:** The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding

Advair Diskus: inhaled corticosteroids + long-acting beta agonist
**ID:** OG000
**Title:** ECS + Medication Group
##### Group
**Description:** inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Advair Diskus: inhaled corticosteroids + long-acting beta agonist
**ID:** OG001
**Title:** Medication Group Alone
#### Outcome Measure 4
**Description:** Number of asthma symptom days in the past two weeks will be a measure of asthma control.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** participants who completed the final follow-up visit at 6 months.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Asthma Symptom Days
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding

Advair Diskus: inhaled corticosteroids + long-acting beta agonist
**ID:** OG000
**Title:** ECS + Medication Group
##### Group
**Description:** inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Advair Diskus: inhaled corticosteroids + long-acting beta agonist
**ID:** OG001
**Title:** Medication Group Alone
#### Outcome Measure 5
**Description:** Asthma exacerbations will be assessed by number of acute visits to the emergency department (ED), hospitalizations and urgent doctor visits.
**Parameter Type:** NUMBER
**Population Description:** participants completing the 6 month follow-up visit
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Asthma Exacerbations
**Type:** SECONDARY
**Unit of Measure:** acute visits
##### Group
**Description:** The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding

Advair Diskus: inhaled corticosteroids + long-acting beta agonist
**ID:** OG000
**Title:** ECS + Medication Group
##### Group
**Description:** inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Advair Diskus: inhaled corticosteroids + long-acting beta agonist
**ID:** OG001
**Title:** Medication Group Alone
#### Outcome Measure 6
**Description:** Forced expiratory volume at one second/forced vital capacity (FEV1/FVC) will be evaluated as a continuous variable. This is a ratio without any units.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** participants completing the 6 month follow-up visit
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** FEV1/FVC
**Type:** SECONDARY
**Unit of Measure:** ratio
##### Group
**Description:** The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding

Advair Diskus: inhaled corticosteroids + long-acting beta agonist
**ID:** OG000
**Title:** ECS + Medication Group
##### Group
**Description:** inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Advair Diskus: inhaled corticosteroids + long-acting beta agonist
**ID:** OG001
**Title:** Medication Group Alone
### Participant Flow Module
#### Group
**Description:** The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding

Advair Diskus: inhaled corticosteroids + long-acting beta agonist
**ID:** FG000
**Title:** ECS + Medication Group
#### Group
**Description:** inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus)

Flovent Diskus: Inhaled corticosteroids

Advair Diskus: inhaled corticosteroids + long-acting beta agonist
**ID:** FG001
**Title:** Medication Group Alone
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 77
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 78
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 57
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 58
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
**Has Results:** True