Indoor Air Pollution and Children With Asthma: An Intervention Trial
CAPS
Indoor Nitrogen Dioxide Exposure and Children With Asthma: An Intervention Trial
2 other identifiers
interventional
116
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable asthma
Started Jan 2016
Longer than P75 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2014
CompletedFirst Posted
Study publicly available on registry
October 8, 2014
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedNovember 23, 2020
November 1, 2020
3.7 years
October 2, 2014
November 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Days with symptoms
The maximum of the following variables reported over the 2-week recall period: (1) number of days with wheezing, chest tightness, or persistent cough; (2) number of nights of sleep disturbance; (3) number of days when activities were affected.
Final 14 days of intervention
Secondary Outcomes (9)
Days of wheeze
Post 4 week intervention
Night symptoms
Post 4 week intervention
Rescue medication use
Post 4 week intervention
Symptom Score
Last 4 weeks of intervention
Amount of Restricted Activity
Post 4 week intervention
- +4 more secondary outcomes
Study Arms (6)
NO2 Scrubber, then HEPA filter, then Control
EXPERIMENTALParticipants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of NO2 Scrubber, then HEPA filter, then Control.
NO2 Scrubber, then Control, then HEPA filter
EXPERIMENTALParticipants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of NO2 Scrubber, then Control, then HEPA filter
HEPA filter, then NO2 scrubber, then Control
EXPERIMENTALParticipants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of HEPA filter, then NO2 scrubber, then Control
HEPA filter, then Control, then NO2 scrubber
EXPERIMENTALParticipants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of HEPA filter, then Control, then NO2 scrubber
Control, then HEPA filter, then NO2 scrubber
EXPERIMENTALParticipants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of Control, then HEPA filter, then NO2 scrubber
Control, then NO2 scrubber, then HEPA filter
EXPERIMENTALParticipants will have 3 periods of 4 weeks with each filter with a 1 week washout between phases in the order of Control, then NO2 scrubber, then HEPA filter
Interventions
an NO2 scrubber that removes NO2 and particles
a HEPA filter that removes 95% of suspended particles ≥ 0.003 μm in size (but does not remove NO2)
a "control" filter designed to be the same size and weight as the other two filters, but filters neither NO2 nor particles
Eligibility Criteria
You may qualify if:
- years of age, enrolled in grades K-5 and living in the recruitment area (CT, MA)
- \[The screening questionnaire will determine asthma symptoms in the past 12 months (wheeze, persistent cough, shortness of breath, chest tightness); and asthma medication use in the past 12 months (short-acting β2-agonists, long-acting β2-agonists, inhaled steroids, oral steroids, theophylline, cromones, and/or leukotriene inhibitors). Based on symptoms and medication, asthma severity will be categorized with a score adapted from the Global Initiative for Asthma guidelines (1=mild transient, 2=mild persistent, 3=moderate, 4=severe). Only children in categories 2 (mild persistent, 3 (moderate) or 4 (severe) will be eligible.\]
You may not qualify if:
- Using steroid medication for a condition other than asthma
- Chronic respiratory condition other than asthma
- Intention to move or relocate within 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Harvard Universitycollaborator
- National Institute of Environmental Health Sciences (NIEHS)collaborator
Study Sites (1)
Yale University
New Haven, Connecticut, 06520, United States
Related Publications (1)
Gent JF, Holford TR, Bracken MB, Plano JM, McKay LA, Sorrentino KM, Koutrakis P, Leaderer BP. Childhood asthma and household exposures to nitrogen dioxide and fine particles: a triple-crossover randomized intervention trial. J Asthma. 2023 Apr;60(4):744-753. doi: 10.1080/02770903.2022.2093219. Epub 2022 Jul 7.
PMID: 35796019DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Leaderer, PhD, MPH
Yale University
- PRINCIPAL INVESTIGATOR
Michael Bracken, PhD MPH FACE
Yale University
- PRINCIPAL INVESTIGATOR
Theodore Holford, PhD
Yale University
- PRINCIPAL INVESTIGATOR
Janneane Gent, PhD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2014
First Posted
October 8, 2014
Study Start
January 1, 2016
Primary Completion
August 31, 2019
Study Completion
August 31, 2019
Last Updated
November 23, 2020
Record last verified: 2020-11