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Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma
This study has been completed.
Study NCT00006565   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: December 1, 2000   Last Updated: October 22, 2008   History of Changes

December 1, 2000
October 22, 2008
September 2000
March 2003   (final data collection date for primary outcome measure)
Unscheduled asthma visits [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00006565 on ClinicalTrials.gov Archive Site
  • Asthma symptoms [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]
  • Exhaled nitric oxide [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]
  • Tobacco smoke exposure, measured using air nicotine dosimeters, serum cotinine and hair cotinine [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]
Same as current
 
Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma
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.

Phase III
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
  • Asthma
  • Lung Diseases
  • Device: HEPA Air Cleaner
  • Device: Placebo Filtration Unit
  • Experimental: HEPA Air Cleaners
  • Placebo Comparator: Inactive (placebo) filtration unit

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
225
April 2004
March 2003   (final data collection date for primary outcome measure)

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
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00006565
Bruce P. Lanphear, MD, MPH, Simon Fraser University
136
National Heart, Lung, and Blood Institute (NHLBI)
 
Principal Investigator: Bruce P Lanphear, MD, MPH Simon Fraser University
National Heart, Lung, and Blood Institute (NHLBI)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP