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
About this trial
This is an interventional prevention trial for Asthma focused on measuring asthma, HEPA, ETS
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
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
NCT ID
NCT00006565
First Posted
December 1, 2000
Last Updated
February 17, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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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