Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00006565

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma Smoking Smoking and Youth

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
1: Experimental HEPA Air Cleaners	Device: HEPA Air Cleaner Placement of two active HEPA air cleaners in the homes of children
2: Placebo Comparator 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:

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.

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.

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.

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.

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

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

asthma
HEPA
ETS

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 25, 2009