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Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00006565
First received: December 1, 2000
Last updated: October 22, 2008
Last verified: October 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
Lung Diseases
 Device: HEPA Air Cleaner
Device: Placebo Filtration Unit
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Unscheduled asthma visits [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 225
Study Start Date: September 2000
Study Completion Date: April 2004
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
HEPA Air Cleaners
 Device: HEPA Air Cleaner
Placement of two active HEPA air cleaners in the homes of children
Other Name: Austin Healthmate HEPA air cleaner
Placebo Comparator: 2
Inactive (placebo) filtration unit
 Device: Placebo Filtration Unit
Placement of inactive filtration unit in the homes

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006565

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Bruce P Lanphear, MD, MPH Simon Fraser University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bruce P. Lanphear, MD, MPH, Simon Fraser University
ClinicalTrials.gov Identifier: NCT00006565     History of Changes
Other Study ID Numbers: 136
Study First Received: December 1, 2000
Last Updated: October 22, 2008
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
asthma
HEPA
ETS

Additional relevant MeSH terms:
Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013