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Home > "R" Clinical Trials Conditions > Randomized Trial to Reduce Environmental Tobacco Smoke in Children with Asthma  Randomized Trial to Reduce Environmental Tobacco Smoke in Children with Asthma
Randomized Trial to Reduce Environmental Tobacco Smoke in Children with Asthma
For Condition: Asthma,Lung Diseases
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To test the effects of reducing indoor environmental tobacco smoke (ETS) on asthma symptoms, pulmonary function, airway inflammation, and health services utilization.
Details: 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 240 children with doctor-diagnosed asthma who are exposed to environmental tobacco smoke tests the efficacy of reducing such exposure on asthma symptoms. The intervention consists of placement of 2 high efficiency air filtration with activated carbon, potassium permanganate and zeolite filter insert (HEPA-CPZ) 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 significant improvements in asthma symptoms and pulmonary function compared with children in the control group. (1.1) Children assigned to the ETS reduction group will have greater than 25 percent reduction in exacerbations of asthma during one year of follow-up compared with those in the control group. (1.2) Children assigned to the ETS reduction group will have improvement in pulmonary function as measured by greater than 10 percent difference in forced expiratory volume at 1 second (FEV 1) and greater than 15 percent difference in forced expiratory fraction of 25 percent-75 percent (FEF25-75 percent) at 12-month follow-up compared with those in the control group. (1.3) Children assigned to the ETS reduction group will have greater than 10 percent reduction in exhaled nitric oxide, a measure of airway inflammation during one year of follow-up compared with the control group. (1.4) Children assigned to the ETS reduction group will have a greater than 20 percent reduction in health services utilization for asthma during one-year follow-up compared with those in the control group. (2.0) Children who are exposed to higher levels of ETS, as measured by cotinine, will experience higher rates of asthma symptoms and diminished pulmonary function in a dose-response relationship.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BruceLanphear, , Children's Hospital Medical Center
Children's Hospital Medical Center *Recruiting*
Cincinnati, Ohio, 45229-3039
United States
Recruiting Bruce Lanphear 513-636-3778
Additional Information:
Study ID Numbers: 136;
Study Start Date: September 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006565
Other Lung Diseases Studies:
1. Longitudinal Study of Asthma From Birth to Adulthood
2. Honolulu Heart Program
3. Asthma Severity in Children and Environmental Agents
4. Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma
5. Epidemiology of Airway Responsiveness
Related Studies:
Other Lung Diseases Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
Randomized Trial to Reduce Environmental Tobacco Smoke in Children with Asthma
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