Comparative Effectiveness of Environmental Intervention and Standard Care in Ability to Reduce Pharmacologic Therapy for Asthma (ERA)
|ClinicalTrials.gov Identifier: NCT01593111|
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : February 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Other: Environmental Intervention||Not Applicable|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||243 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Comparative Effectiveness of Environmental Intervention and Standard Care in Ability to Reduce Pharmacologic Therapy for Asthma|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Experimental: Environmental Intervention
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.
Other: Environmental Intervention
Home-based environmental intervention
No Intervention: Control Group
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).
- Step down of medication [ Time Frame: V4-V7 (every two months) ]Based on subject's lung function and symptoms
- Change in allergen specific serum IgE levels [ Time Frame: Visit 3, Visit 5 and Visit 8 (approximately every 4 months) ]Blood test
- Change in airway hyper-responsiveness [ Time Frame: Visit 1 and Visit 7 (initial visit and at month 10) ]As determined by Methacholine Challenge
- Fractional excretion of nitric oxide [ Time Frame: V3-V8 (every two months) ]Measured by Aerocrine Mino
- Asthma symptom score [ Time Frame: V3-V8 (every two months) ]Standardized questionnaire
- Asthma exacerbations [ Time Frame: Every visit (every two weeks for two months, then every two months) ]Patient reported outcome
- lung function [ Time Frame: Every visit (every month for two months, then every two months) ]spirometry pulmonary function testing
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593111
|United States, New York|
|Jacobi Medical Center|
|Bronx, New York, United States, 10461|
|Columbia Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Emily DiMango, MD||Columbia University|