Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2004-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma Lung Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

HEPA Air Cleaners

Group Type EXPERIMENTAL

HEPA Air Cleaner

Intervention Type DEVICE

Placement of two active HEPA air cleaners in the homes of children

2

Inactive (placebo) filtration unit

Group Type PLACEBO_COMPARATOR

Placebo Filtration Unit

Intervention Type DEVICE

Placement of inactive filtration unit in the homes

Interventions

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HEPA Air Cleaner

Placement of two active HEPA air cleaners in the homes of children

Intervention Type DEVICE

Placebo Filtration Unit

Placement of inactive filtration unit in the homes

Intervention Type DEVICE

Other Intervention Names

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Austin Healthmate HEPA air cleaner

Eligibility Criteria

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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