Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma

February 17, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
HEPA Air Cleaners
Device: HEPA Air Cleaner
Placement of two active HEPA air cleaners in the homes of children
Other Names:
  • Austin Healthmate HEPA air cleaner
Placebo Comparator: 2
Inactive (placebo) filtration unit
Device: Placebo Filtration Unit
Placement of inactive filtration unit in the homes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Unscheduled asthma visits
Time Frame: Measured at 12 months
Measured at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Asthma symptoms
Time Frame: Measured at 12 months
Measured at 12 months
Exhaled nitric oxide
Time Frame: Measured at 12 months
Measured at 12 months
Tobacco smoke exposure, measured using air nicotine dosimeters, serum cotinine and hair cotinine
Time Frame: Measured at 12 months
Measured at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Bruce P Lanphear, MD, MPH, Simon Fraser University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

December 1, 2000

First Submitted That Met QC Criteria

November 30, 2000

First Posted (Estimate)

December 1, 2000

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 136
  • R01HL065731 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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