Indoor Air Pollution and Children With Asthma: An Intervention Trial
NCT ID: NCT02258893
Last Updated: 2020-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
116 participants
INTERVENTIONAL
2016-01-01
2019-08-31
Brief Summary
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Detailed Description
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Families with asthmatic children age 5-11 will be recruited from selected communities using a: (1) flyers distributed in elementary schools, (2) postcards send to families from purchased mailing lists, (3) posters placed in community buildings (libraries, clinics, etc.), (4) online (Facebook, Craigslist), and (5) letter mailed to families targeted through Yale Joint Data Analytics Team (JDAT). Volunteers will be screened for preliminary eligibility based on household characteristics and active asthmatic status. Potentially eligible families will have homes with a gas cooking stove and seven rooms or fewer. Potentially eligible children will be aged 5-11; have asthma symptoms and/or medication use consistent with severity score categories 2 (mild persistent), 3 (moderate), or 4 (severe) during the previous 12 months; and reside at least 5 days and nights every week in the eligible home.
Households meeting these preliminary criteria will be asked to participate in passive NO2 sampling. A single Palmes tube 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 enrollment of more than one eligible child per family. Participating families will be randomized into one of 6 treatment sequences each requiring 3 periods of 4-weeks preceded by a 1-week washout period. Randomization will be blocked so that for every 18 subjects randomized there will be 3 in each sequence. Randomization will be conducted blindly by the data management department such that each scheduled initial interview/air cleaner installation is assigned a treatment sequence (referring to machines and filters already on site). Minimization techniques will be used to balance the randomized allocation as necessary. Total subject participation time up to 18 weeks.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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NO2 Scrubber, then HEPA filter, then Control
Participants 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
an NO2 scrubber that removes NO2 and particles
HEPA filter
a HEPA filter that removes 95% of suspended particles ≥ 0.003 μm in size (but does not remove NO2)
Control
a "control" filter designed to be the same size and weight as the other two filters, but filters neither NO2 nor particles
NO2 Scrubber, then Control, then HEPA filter
Participants 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
NO2 Scrubber
an NO2 scrubber that removes NO2 and particles
HEPA filter
a HEPA filter that removes 95% of suspended particles ≥ 0.003 μm in size (but does not remove NO2)
Control
a "control" filter designed to be the same size and weight as the other two filters, but filters neither NO2 nor particles
HEPA filter, then NO2 scrubber, then Control
Participants 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
NO2 Scrubber
an NO2 scrubber that removes NO2 and particles
HEPA filter
a HEPA filter that removes 95% of suspended particles ≥ 0.003 μm in size (but does not remove NO2)
Control
a "control" filter designed to be the same size and weight as the other two filters, but filters neither NO2 nor particles
HEPA filter, then Control, then NO2 scrubber
Participants 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
NO2 Scrubber
an NO2 scrubber that removes NO2 and particles
HEPA filter
a HEPA filter that removes 95% of suspended particles ≥ 0.003 μm in size (but does not remove NO2)
Control
a "control" filter designed to be the same size and weight as the other two filters, but filters neither NO2 nor particles
Control, then HEPA filter, then NO2 scrubber
Participants 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
NO2 Scrubber
an NO2 scrubber that removes NO2 and particles
HEPA filter
a HEPA filter that removes 95% of suspended particles ≥ 0.003 μm in size (but does not remove NO2)
Control
a "control" filter designed to be the same size and weight as the other two filters, but filters neither NO2 nor particles
Control, then NO2 scrubber, then HEPA filter
Participants 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
NO2 Scrubber
an NO2 scrubber that removes NO2 and particles
HEPA filter
a HEPA filter that removes 95% of suspended particles ≥ 0.003 μm in size (but does not remove NO2)
Control
a "control" filter designed to be the same size and weight as the other two filters, but filters neither NO2 nor particles
Interventions
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NO2 Scrubber
an NO2 scrubber that removes NO2 and particles
HEPA filter
a HEPA filter that removes 95% of suspended particles ≥ 0.003 μm in size (but does not remove NO2)
Control
a "control" filter designed to be the same size and weight as the other two filters, but filters neither NO2 nor particles
Eligibility Criteria
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Inclusion Criteria
* \[The screening questionnaire will determine asthma symptoms in the past 12 months (wheeze, persistent cough, shortness of breath, chest tightness); and asthma medication use in the past 12 months (short-acting β2-agonists, long-acting β2-agonists, inhaled steroids, oral steroids, theophylline, cromones, and/or leukotriene inhibitors). Based on symptoms and medication, asthma severity will be categorized with a score adapted from the Global Initiative for Asthma guidelines (1=mild transient, 2=mild persistent, 3=moderate, 4=severe). Only children in categories 2 (mild persistent, 3 (moderate) or 4 (severe) will be eligible.\]
Exclusion Criteria
* Chronic respiratory condition other than asthma
* Intention to move or relocate within 6 months
5 Years
11 Years
ALL
No
Sponsors
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Harvard University
OTHER
National Institute of Environmental Health Sciences (NIEHS)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Brian Leaderer, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Yale University
Michael Bracken, PhD MPH FACE
Role: PRINCIPAL_INVESTIGATOR
Yale University
Theodore Holford, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Janneane Gent, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
Countries
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References
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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.
Other Identifiers
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1308012531
Identifier Type: -
Identifier Source: org_study_id