Environmental Intervention Versus Standard Care to Reduce Pharmacologic Therapy for Asthma

NCT01593111 | Completed DMC

• 1 other identifier: AAAF3904
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Step down of medication

  Based on subject's lung function and symptoms

  V4-V7 (every two months)

Secondary Outcomes (6)

• Change in allergen specific serum IgE levels

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

• Change in airway hyper-responsiveness

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

• Fractional excretion of nitric oxide

  V3-V8 (every two months)

• Asthma symptom score

  V3-V8 (every two months)

• Asthma exacerbations

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

Study Arms (2)

Environmental Intervention

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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).

Interventions

Environmental Intervention OTHER

Home-based environmental intervention

Environmental Intervention

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (2)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Asthma; Hypersensitivity; Respiratory Aspiration

Interventions

Milieu Therapy

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Emily DiMango, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: May 7, 2012
• Study Start: April 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 4, 2022

Record last verified: 2022-01

Locations

US (2)