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.
Status | Completed |
Enrollment | 225 |
Est. completion date | April 2004 |
Est. primary completion date | March 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 12 Years |
Eligibility |
Inclusion Criteria: - Age 6-12 years at enrollment - Doctor diagnosed asthma by ICD-9 billing codes (from billing records) - Greater than 1 exacerbation(s) in the past year requiring an unscheduled asthma visit - Exposed to the smoke of greater than or equal to 5 cigarettes in and around the house per day - Lived within a 9-county area surrounding the city of Cincinnati Exclusion Criteria: - Already using a HEPA air cleaner - Lacked electricity - Had a coexisting medical problem - Family planned to move in the next year |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
Spanier AJ, Hornung R, Lierl M, Lanphear BP. Environmental exposures and exhaled nitric oxide in children with asthma. J Pediatr. 2006 Aug;149(2):220-6. — View Citation
Spanier AJ, Hornung RW, Kahn RS, Lierl MB, Lanphear BP. Seasonal variation and environmental predictors of exhaled nitric oxide in children with asthma. Pediatr Pulmonol. 2008 Jun;43(6):576-83. doi: 10.1002/ppul.20816. — View Citation
Wilson SE, Kahn RS, Khoury J, Lanphear BP. Racial differences in exposure to environmental tobacco smoke among children. Environ Health Perspect. 2005 Mar;113(3):362-7. — View Citation
Wilson SE, Kahn RS, Khoury J, Lanphear BP. The role of air nicotine in explaining racial differences in cotinine among tobacco-exposed children. Chest. 2007 Mar;131(3):856-62. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Unscheduled asthma visits | Measured at 12 months | No | |
Secondary | Asthma symptoms | Measured at 12 months | No | |
Secondary | Exhaled nitric oxide | Measured at 12 months | No | |
Secondary | Tobacco smoke exposure, measured using air nicotine dosimeters, serum cotinine and hair cotinine | Measured at 12 months | No |
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