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Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma

Primary Purpose

Asthma, Lung Diseases

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
HEPA Air Cleaner
Placebo Filtration Unit
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring asthma, HEPA, ETS

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    HEPA Air Cleaners

    Inactive (placebo) filtration unit

    Outcomes

    Primary Outcome Measures

    Unscheduled asthma visits

    Secondary Outcome Measures

    Asthma symptoms
    Exhaled nitric oxide
    Tobacco smoke exposure, measured using air nicotine dosimeters, serum cotinine and hair cotinine

    Full Information

    First Posted
    December 1, 2000
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00006565
    Brief Title
    Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma
    Official Title
    Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2000 (undefined)
    Primary Completion Date
    March 2003 (Actual)
    Study Completion Date
    April 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma, Lung Diseases
    Keywords
    asthma, HEPA, ETS

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    225 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    HEPA Air Cleaners
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Inactive (placebo) filtration unit
    Intervention Type
    Device
    Intervention Name(s)
    HEPA Air Cleaner
    Other Intervention Name(s)
    Austin Healthmate HEPA air cleaner
    Intervention Description
    Placement of two active HEPA air cleaners in the homes of children
    Intervention Type
    Device
    Intervention Name(s)
    Placebo Filtration Unit
    Intervention Description
    Placement of inactive filtration unit in the homes
    Primary Outcome Measure Information:
    Title
    Unscheduled asthma visits
    Time Frame
    Measured at 12 months
    Secondary Outcome Measure Information:
    Title
    Asthma symptoms
    Time Frame
    Measured at 12 months
    Title
    Exhaled nitric oxide
    Time Frame
    Measured at 12 months
    Title
    Tobacco smoke exposure, measured using air nicotine dosimeters, serum cotinine and hair cotinine
    Time Frame
    Measured at 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bruce P Lanphear, MD, MPH
    Organizational Affiliation
    Simon Fraser University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15743729
    Citation
    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. doi: 10.1289/ehp.7379.
    Results Reference
    result
    PubMed Identifier
    18429012
    Citation
    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. doi: 10.1002/ppul.20816.
    Results Reference
    result
    PubMed Identifier
    16887438
    Citation
    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. doi: 10.1016/j.jpeds.2006.04.001.
    Results Reference
    result
    PubMed Identifier
    17356104
    Citation
    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):856-862. doi: 10.1378/chest.06-2123.
    Results Reference
    result
    PubMed Identifier
    21149427
    Citation
    Lanphear BP, Hornung RW, Khoury J, Yolton K, Lierl M, Kalkbrenner A. Effects of HEPA air cleaners on unscheduled asthma visits and asthma symptoms for children exposed to secondhand tobacco smoke. Pediatrics. 2011 Jan;127(1):93-101. doi: 10.1542/peds.2009-2312. Epub 2010 Dec 13.
    Results Reference
    derived

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    Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma

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