Ignite Creation Date:
2024-05-06 @ 3:16 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02258893
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2014-10-02
Brief Title:
Indoor Air Pollution and Children With Asthma An Intervention Trial
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Indoor Nitrogen Dioxide Exposure and Children With Asthma An Intervention Trial
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPS
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 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 eg 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 andor 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 interviewair 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
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 andor 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 interviewair 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01ES023505-05 | NIH | None | httpsreporternihgovquickSearch5R01ES023505-05 |