Status:
COMPLETED
Indoor Air Pollution and Children With Asthma: An Intervention Trial
Lead Sponsor:
Yale University
Collaborating Sponsors:
Harvard University
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Asthma
Eligibility:
All Genders
5-11 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether reducing indoor exposure to NO2 and particles improves respiratory health in children with asthma.
Detailed Description
We have designed a randomized, double-blind, triple cross-over intervention study to examine the efficacy of indoor NO2 reduction on reducing asthma severity. Since particles and NO2 are both byproduc...
Eligibility Criteria
Inclusion
- 5-11 years of age, enrolled in grades K-5 and living in the recruitment area (CT, MA)
- \[The screening questionnaire will determine asthma symptoms in the past 12 months (wheeze, persistent cough, shortness of breath, chest tightness); and asthma medication use in the past 12 months (short-acting β2-agonists, long-acting β2-agonists, inhaled steroids, oral steroids, theophylline, cromones, and/or leukotriene inhibitors). Based on symptoms and medication, asthma severity will be categorized with a score adapted from the Global Initiative for Asthma guidelines (1=mild transient, 2=mild persistent, 3=moderate, 4=severe). Only children in categories 2 (mild persistent, 3 (moderate) or 4 (severe) will be eligible.\]
- For potential subjects satisfying these inclusion criteria, a passive NO2 monitor will be sent to the home for placement in the main living space for one week. Families will be called after one week and instructed to cap and return the NO2 monitor in a pre-paid mailer. Families of children living in homes where the one-week integrated average NO2 concentration is ≥ 15 ppb will be invited to participate. We will permit the enrollment of more than one eligible child per family.
Exclusion
- Using steroid medication for a condition other than asthma
- Chronic respiratory condition other than asthma
- Intention to move or relocate within 6 months
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT02258893
Start Date
January 1 2016
End Date
August 31 2019
Last Update
November 23 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University
New Haven, Connecticut, United States, 06520