What is the purpose of this trial?
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 one level or more improvement in the severity score and whether reducing exposure to particles ≥ 0.003 μm alone (without concurrent reduction in NO2) reduces asthma severity.
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, and (3) posters placed in community buildings (libraries, clinics, etc.). 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 fewer than seven rooms. 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 > 20 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.
Ages: 5 - 11 years
National Institute of Environmental Health Sciences
Dates: 01/25/2016 - 08/31/2018
Last Updated: 07/28/2016
Study HIC#: 1308012531