- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02258893
Indoor Air Pollution and Children With Asthma: An Intervention Trial (CAPS)
Indoor Nitrogen Dioxide Exposure and Children With Asthma: An Intervention Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 byproducts of combustion and associated with gas stove use, the intervention protocol includes a condition using a filter designed to remove particles also implicated in asthma exacerbations (e.g., coarse, fine and ultrafine particles including airborne mold spores and allergens) while leaving NO2 virtually untouched. Primary and secondary aims of the trial include, respectively, determining whether reducing exposure to NO2 and particles compared to a "control" (non-filtered) condition results in a clinically significant reduction in asthma severity measured by a difference in days of symptoms between intervention arms.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
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New Haven, Connecticut, United States, 06520
- Yale University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- Using steroid medication for a condition other than asthma
- Chronic respiratory condition other than asthma
- Intention to move or relocate within 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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
|
Experimental: 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
|
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
|
Experimental: 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
|
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
|
Experimental: 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
|
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
|
Experimental: 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
|
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
|
Experimental: 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days with symptoms
Time Frame: Final 14 days of intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days of wheeze
Time Frame: Post 4 week intervention
|
As measured by self report
|
Post 4 week intervention
|
Night symptoms
Time Frame: Post 4 week intervention
|
As measured by self report
|
Post 4 week intervention
|
Rescue medication use
Time Frame: Post 4 week intervention
|
As measured by self report
|
Post 4 week intervention
|
Symptom Score
Time Frame: Last 4 weeks of intervention
|
The score is adapted from the Global Initiative for Asthma Guidelines which incorporates type and frequency of symptoms and medications.
The symptom score portion, is a 5-level score calculated based on symptoms during the last 4-weeks of the intervention.
|
Last 4 weeks of intervention
|
Amount of Restricted Activity
Time Frame: Post 4 week intervention
|
Activity Restrictions as measured by self report
|
Post 4 week intervention
|
Number of Missed days of school
Time Frame: Post 4 week intervention
|
As measured by self report
|
Post 4 week intervention
|
Number of Hospitalizations
Time Frame: Post 4 week intervention
|
As measured by self report
|
Post 4 week intervention
|
Number of Emergency Room Visits
Time Frame: Post 4 week intervention
|
As measured by self report
|
Post 4 week intervention
|
Number of Doctors Visits
Time Frame: Post 4 week intervention
|
As measured by self report
|
Post 4 week intervention
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1308012531
- 5R01ES023505-05 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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