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Environmental Intervention Versus Standard Care to Reduce Pharmacologic Therapy for Asthma (ERA)

Primary Purpose

Asthma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Environmental Intervention

About this trial

This is an interventional prevention trial for Asthma focused on measuring Allergies, Asthma, Environmental, NYC, Manhattan, Harlem, Bronx, Brooklyn, Breathing, eNO, IgE, Allergens, Cockroach, Dust mites, Pets

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical history consistent with asthma in male and female subjects ages 6 and above.
Need for controller therapy demonstrated by current use of a stable dose (at least 4 weeks) of long term asthma controller therapy; or if not receiving long term asthma controller, symptoms consistent with persistent asthma (eg. Symptoms > 3x per week).
Prebronchodilator FEV1 > 40% predicted at screening (V0)
Positive skin test (defined as wheal greater than 3 mm in diameter greater than saline negative control) to protein extracts of at least one of 9 common indoor allergens including dust mites, cockroach mix, rat, mouse, Alternaria, Cladosporium, Aspergillus, cat and dog tested at Visit 0 (or positive RAST test to at least on aeroallergen if FEV1<60% at Visit 0 precluding allergen skin testing.)
Evidence of at least one allergen in household dust which matches skin test positivity or RAST testing (overlap to be checked and recorded at V3).
Asthma confirmed by either reversibility to 4 puffs albuterol greater than or equal to 12% in FEV1 at V0 OR PC20 FEV1 methacholine of less than or equal 16 mg/ml at or up to 30 days previous to V1.
Sleeps overnight at same address at least 5 times per week.

Exclusion Criteria:

Significant medical illness other than asthma including other chronic respiratory illness (eg emphysema, cystic fibrosis)
Currently receiving immunotherapy or received such therapy in the past year
Emergency Department (ED) visit for asthma or steroid taper within the past 2 weeks (may be rescreened at a future date).
Investigational drug within the past 30 days; anti-IgE therapy within past 6 months
Active smoker or greater than 10 pack year history of asthma
Asthma requiring mechanical ventilation within the past 5 years
Significant occupational exposures as determined by principal investigator.

Sites / Locations

Jacobi Medical Center
Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Environmental Intervention

Control Group

Arm Description

If randomized to this part of the study the patient will receive an individualized homebased program. In addition to general handouts provided to at Visit 3, subjects in this arm will also receive home-based education by Intervention Counselors about how indoor allergens can affect asthma and the importance of strategies for removing allergens. The goal of the intervention is to provide the patient with the knowledge and skills necessary to remove allergens from their home, and to assist them with those clean up measures. Some of the measures implemented will be specifically based on data we have previously collected from them in the clinic and from their previous home visit, while others will be general to reduce all allergen level.

If assigned to this group the patient will receive general health/safety related counseling. At the counselor visit following randomization, the patient will receive handouts related to general health and safety issues. They will also have visits by the Home Evaluators for assessment of the home and collection of dust samples identical to those in the treatment group (week 28 and week 44).

Outcomes

Primary Outcome Measures

Step down of medication

Based on subject's lung function and symptoms

Secondary Outcome Measures

Change in allergen specific serum IgE levels

Blood test

Change in airway hyper-responsiveness

As determined by Methacholine Challenge

Fractional excretion of nitric oxide

Measured by Aerocrine Mino

Asthma symptom score

Standardized questionnaire

Asthma exacerbations

Patient reported outcome

lung function

spirometry pulmonary function testing

Full Information

NCT ID

NCT01593111

First Posted

February 27, 2012

Last Updated

January 21, 2022

Sponsor

Columbia University

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

1. Study Identification

Unique Protocol Identification Number

NCT01593111

Brief Title

Environmental Intervention Versus Standard Care to Reduce Pharmacologic Therapy for Asthma

Acronym

ERA

Official Title

Comparative Effectiveness of Environmental Intervention and Standard Care in Ability to Reduce Pharmacologic Therapy for Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Exposure to household allergens is a major contributor to asthma symptoms. Aggressive measures to reduce household allergens has the potential to reduce asthma symptoms and the need for medications to control asthma. The investigators plan to enroll patients aged 6 and above into a single blind, randomized study comparing intensive environmental intervention with usual asthma care over a 48 week study period. All subjects will have asthma treatment optimized according to guideline based care. Subjects will be randomized to an aggressive environmental remediation arm versus distribution of written materials regarding allergen reduction ("usual care"). Primary outcome measure will be ability to reduce asthma step therapy. Secondary outcomes include measures of lung function, asthma biomarkers and quality of life.

Detailed Description

Research question(s): In individuals with atopic asthma who are being treated with inhaled corticosteroids with or without long acting beta agonists (1 of 6 possible steps of treatment), aggressive environmental intervention to reduce exposure to home allergens is more likely to lead to one step reduction in asthma controller therapy, improved asthma control and improved biomarkers of airway inflammation than is usual care. Scientific abstract: Environmental exposure to indoor allergens is a major contributor to asthma impairment and risk, particularly among asthmatic patients residing in inner cities. The investigators plan a randomized controlled trial to assess the effect of individualized, comprehensive, multifaceted indoor allergen avoidance measures on ability to step down asthma controller therapy in adults and children greater than 6 years with mild to severe persistent asthma. Specifically, 1. To determine via a randomized, controlled trial in allergen sensitized asthma patients whether environmental intervention aimed at reducing exposure to indoor allergens and irritants is more effective in reducing National Asthma Education and Prevention Program (NAEPP) step based therapy than usual care over a 48 week study period. 2a. To determine if environmental intervention leads to reduction in indoor allergen levels, allergen specific serum IgE levels, airway hyper-responsiveness, fractional excretion of nitric oxide, asthma symptom score, asthma exacerbations, treatment failures and improved lung function compared to usual care over a 48 week study period. 2b. (Exploratory): To determine if there is an association between reduction in allergen specific IgE level and reduction in NAEPP step level required for asthma control among subjects randomized to environmental intervention compared with usual care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Allergies, Asthma, Environmental, NYC, Manhattan, Harlem, Bronx, Brooklyn, Breathing, eNO, IgE, Allergens, Cockroach, Dust mites, Pets

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

243 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Environmental Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

Environmental Intervention

Intervention Description

Home-based environmental intervention

Primary Outcome Measure Information:

Title

Step down of medication

Description

Based on subject's lung function and symptoms

Time Frame

V4-V7 (every two months)

Secondary Outcome Measure Information:

Title

Change in allergen specific serum IgE levels

Description

Blood test

Time Frame

Visit 3, Visit 5 and Visit 8 (approximately every 4 months)

Title

Change in airway hyper-responsiveness

Description

As determined by Methacholine Challenge

Time Frame

Visit 1 and Visit 7 (initial visit and at month 10)

Title

Fractional excretion of nitric oxide

Description

Measured by Aerocrine Mino

Time Frame

V3-V8 (every two months)

Title

Asthma symptom score

Description

Standardized questionnaire

Time Frame

V3-V8 (every two months)

Title

Asthma exacerbations

Description

Patient reported outcome

Time Frame

Every visit (every two weeks for two months, then every two months)

Title

lung function

Description

spirometry pulmonary function testing

Time Frame

Every visit (every month for two months, then every two months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical history consistent with asthma in male and female subjects ages 6 and above. Need for controller therapy demonstrated by current use of a stable dose (at least 4 weeks) of long term asthma controller therapy; or if not receiving long term asthma controller, symptoms consistent with persistent asthma (eg. Symptoms > 3x per week). Prebronchodilator FEV1 > 40% predicted at screening (V0) Positive skin test (defined as wheal greater than 3 mm in diameter greater than saline negative control) to protein extracts of at least one of 9 common indoor allergens including dust mites, cockroach mix, rat, mouse, Alternaria, Cladosporium, Aspergillus, cat and dog tested at Visit 0 (or positive RAST test to at least on aeroallergen if FEV1<60% at Visit 0 precluding allergen skin testing.) Evidence of at least one allergen in household dust which matches skin test positivity or RAST testing (overlap to be checked and recorded at V3). Asthma confirmed by either reversibility to 4 puffs albuterol greater than or equal to 12% in FEV1 at V0 OR PC20 FEV1 methacholine of less than or equal 16 mg/ml at or up to 30 days previous to V1. Sleeps overnight at same address at least 5 times per week. Exclusion Criteria: Significant medical illness other than asthma including other chronic respiratory illness (eg emphysema, cystic fibrosis) Currently receiving immunotherapy or received such therapy in the past year Emergency Department (ED) visit for asthma or steroid taper within the past 2 weeks (may be rescreened at a future date). Investigational drug within the past 30 days; anti-IgE therapy within past 6 months Active smoker or greater than 10 pack year history of asthma Asthma requiring mechanical ventilation within the past 5 years Significant occupational exposures as determined by principal investigator.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emily DiMango, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jacobi Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

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Environmental Intervention Versus Standard Care to Reduce Pharmacologic Therapy for Asthma

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