Asthma Clinical Trial
Official title:
Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma
The purpose of this study is to test the effects of reducing indoor environmental tobacco smoke (ETS) on unscheduled asthma visits, asthma symptoms, airway inflammation, and exposure to tobacco smoke measured using air nicotine dosimeters, serum and hair cotinine.
BACKGROUND:
Asthma, a disease characterized by increased airway reactivity and inflammation in response
to a variety of stimuli, is emerging as the most prevalent and serious environmental health
problem among children in the United States. Numerous studies, both prospective and
cross-sectional, suggest that exposure to ETS is one of the predominate risk factors for
childhood asthma, but this has not been confirmed in a controlled trial.
DESIGN NARRATIVE:
The randomized, double-blind prospective trial involving 225 children with doctor-diagnosed
asthma who are exposed to environmental tobacco smoke tests the efficacy of reducing such
exposure on unscheduled asthma visits and asthma symptoms. The intervention consists of
placement of 2 high efficiency air filtration with activated carbon, potassium permanganate
and zeolite filter insert to reduce exposure to ETS in the experimental homes and inactive
(placebo) units in the control group homes. The following hypotheses are tested. (1.0)
Children assigned to the ETS reduction group will have a greater than 20 percent reduction
in unscheduled asthma visits during one-year follow-up compared with those in the control
group. (1.1) Children assigned to the ETS reduction group will have significant improvements
in asthma symptoms compared with children in the control group. (1.2) Children assigned to
the ETS reduction group will have greater than 10 percent reduction in ETS exposure and
exhaled nitric oxide, a measure of airway inflammation during one year of follow-up compared
with the control group.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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