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Completed

NCT Number: NCT00006565

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.

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Key information

Conditions

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

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HEPA air cleaner

Device

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

Other names: Austin Healthmate HEPA air cleaner

Placebo Filtration Unit

Device

Placement of inactive filtration unit in the homes

Primary outcomes

  1. Unscheduled asthma visits

    Time frame: Measured at 12 months

Secondary outcomes

  1. Asthma symptoms

    Time frame: Measured at 12 months

  2. Exhaled nitric oxide

    Time frame: Measured at 12 months

  3. Tobacco smoke exposure, measured using air nicotine dosimeters, serum cotinine and hair cotinine

    Time frame: Measured at 12 months

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Important dates

Study start
2000
Primary completion
2003
Study completion
2004
First posted
Dec 1, 2000
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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