Randomized Trial to Reduce Environmental Tobacco Smoke in... | NCT00006565

Studies
Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma

NCT00006565

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Status

Completed

Last Update Posted

Feb 18, 2016Estimated

Enrollment

225Actual

Phase

Phase 3

Conditions

Asthma
Lung Diseases

Interventions

HEPA Air Cleaner
Placebo Filtration Unit

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01HL065731	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2000

Primary Completion Date

Mar 2003Actual

Completion Date

Apr 2004Actual

First Submitted Date

Dec 1, 2000

First Submission Date that Met QC Criteria

Nov 30, 2000

First Posted Date

Dec 1, 2000Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2016

Last Update Posted Date

Feb 18, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Heart, Lung, and Blood Institute (NHLBI)NIH

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

225Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	HEPA Air Cleaners	Device: HEPA Air Cleaner
2	Placebo Comparator	Inactive (placebo) filtration unit	Device: Placebo Filtration Unit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HEPA Air Cleaner	Device	Placement of two active HEPA air cleaners in the homes of children	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Unscheduled asthma visits		Measured at 12 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruce P Lanphear, MD, MPH	Simon Fraser University	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15743729	Result	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.
18429012	Result	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.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D012130	Respiratory Hypersensitivity