NCT00006565

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P25-P50 for phase_3 asthma

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_3 asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2000

Completed
Same day until next milestone

First Posted

Study publicly available on registry

December 1, 2000

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
Last Updated

February 18, 2016

Status Verified

October 1, 2008

Enrollment Period

2.5 years

First QC Date

December 1, 2000

Last Update Submit

February 17, 2016

Conditions

AsthmaLung Diseases

Keywords

asthmaHEPAETS

Outcome Measures

Primary Outcomes (1)

  • Unscheduled asthma visits

    Measured at 12 months

Secondary Outcomes (3)

  • Asthma symptoms

    Measured at 12 months

  • Exhaled nitric oxide

    Measured at 12 months

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

    Measured at 12 months

Study Arms (2)

1

EXPERIMENTAL

HEPA Air Cleaners

Device: HEPA Air Cleaner

2

PLACEBO COMPARATOR

Inactive (placebo) filtration unit

Device: Placebo Filtration Unit

Interventions

HEPA Air CleanerDEVICE

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

Also known as: Austin Healthmate HEPA air cleaner
1
Placebo Filtration UnitDEVICE

Placement of inactive filtration unit in the homes

2

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Already using a HEPA air cleaner
  • Lacked electricity
  • Had a coexisting medical problem
  • Family planned to move in the next year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 15743729RESULT

  • 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.

    PMID: 18429012RESULT

  • 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.

    PMID: 16887438RESULT

  • 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.

    PMID: 17356104RESULT

  • 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.

    PMID: 21149427DERIVED

MeSH Terms

Conditions

AsthmaLung Diseases

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Bruce P Lanphear, MD, MPH

    Simon Fraser University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

December 1, 2000

First Posted

December 1, 2000

Study Start

September 1, 2000

Primary Completion

March 1, 2003

Study Completion

April 1, 2004

Last Updated

February 18, 2016

Record last verified: 2008-10