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Randomized Trial to Reduce Environmental Tobacco Smoke in Children with Asthma - Article


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Carbon Monoxide Poisoning

Carbon Monoxide


Clinical Trial: Randomized Trial to Reduce Environmental Tobacco Smoke in Children with Asthma

This study is currently recruiting patients.

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

Purpose

To test the effects of reducing indoor environmental tobacco smoke (ETS) on asthma symptoms, pulmonary function, airway inflammation, and health services utilization.

Condition Treatment or Intervention Phase
Asthma
Lung Diseases
 Procedure: High efficiency air filtration with activated carbon, potassium permanganate, and zeolite filter insert
Phase III

MedlinePlus related topics:  Asthma;   Respiratory Diseases

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind

Further Study Details: 

Study start: September 2000;  Expected completion: July 2005

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

Genders Eligible for Study:  Both

Criteria

No eligibility criteria

Location and Contact Information


Ohio
      Children's Hospital Medical Center, Cincinnati,  Ohio,  45229-3039,  United States; Recruiting
Bruce P. Lanphear  513-636-3778    BRUCE.LANPHEAR@CHMCC.ORG 
Bruce P. Lanphear,  Study Chair

Study chairs or principal investigators

Bruce Lanphear,  Children's Hospital Medical Center   

More Information

Study ID Numbers:  136
Record last reviewed:  March 2005
Last Updated:  March 17, 2005
Record first received:  December 1, 2000
ClinicalTrials.gov Identifier:  NCT00006565
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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