NCT00466024

Brief Summary

The purpose of this study is to conduct a randomized controlled trial of the efficacy of a combination of HEPA room air cleaners plus an ETS reduction behavior training as compared to either HEPA air cleaners plus standard asthma education or delayed HEPA air cleaners and standard asthma education (control group).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P25-P50 for phase_3 asthma

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_3 asthma

Geographic Reach
1 country

1 active site

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

October 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

September 1, 2015

Status Verified

March 1, 2009

Enrollment Period

2.3 years

First QC Date

April 25, 2007

Last Update Submit

August 31, 2015

Conditions

Asthma

Keywords

AsthmapersistentchildrenparticulatesETS

Outcome Measures

Primary Outcomes (1)

  • The primary outcome for this study is reduction in PM10 and PM2.5 over the 6 month follow-up.

    6 months

Secondary Outcomes (1)

  • Secondary outcomes include ETS reduction behavior change (i.e. smoker is smoking outside of home, child not sitting with smoker, reduction in number of household smokers), symptom free days and health care utilization measures.

    6 months

Study Arms (3)

1

EXPERIMENTAL

Health coach and 2 HEPA air cleaners

Behavioral: Health Coach and HEPA Air cleaners

2

ACTIVE COMPARATOR

Standard asthma education and 2 HEPA air cleaners

Behavioral: Health Coach and HEPA air cleaners

3

ACTIVE COMPARATOR

Standard asthma education and delayed receipt of 2 HEPA air cleaners

Behavioral: Health Coach and HEPA air cleaners

Interventions

Health Coach and HEPA air cleanersBEHAVIORAL

Health Coach for ETS reduction in home and 2 HEPA air cleaners

Also known as: Behavior and HEPA
1

Eligibility Criteria

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

You may qualify if:

  • An eligible child will be defined as:
  • Age 6-12 years
  • Doctor's diagnosis of asthma
  • Currently having persistent asthma, defined as asthma symptoms or use of quick reliever asthma medication \> 2 days/week in the last 2 weeks or use of daily controller asthma medication in past 2 weeks based on parent report.
  • Reside in eligible household at least 5 days per week
  • Household:
  • Located in Baltimore
  • Housing an eligible child
  • Housing an English speaking family
  • Housing at least one smoker, who smokes 5 or more cigarettes per day. Smoking in the car will be recorded, but if ETS exposure is limited to the car, the household is not eligible.
  • Having working electricity and no major structural damage.
  • Having no working air cleaner

You may not qualify if:

  • Children will be excluded is they have other respiratory morbidity such as cystic fibrosis or bronchopulmonary dysplasia, if they smoke cigarettes, if they do not have asthma symptoms or medication use in the month before randomization
  • Families living in a shelter or transitional housing will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • Butz AM, Matsui EC, Breysse P, Curtin-Brosnan J, Eggleston P, Diette G, Williams D, Yuan J, Bernert JT, Rand C. A randomized trial of air cleaners and a health coach to improve indoor air quality for inner-city children with asthma and secondhand smoke exposure. Arch Pediatr Adolesc Med. 2011 Aug;165(8):741-8. doi: 10.1001/archpediatrics.2011.111.

    PMID: 21810636DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Arlene M Butz, ScD, RN

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 25, 2007

First Posted

April 27, 2007

Study Start

October 1, 2006

Primary Completion

February 1, 2009

Study Completion

June 1, 2010

Last Updated

September 1, 2015

Record last verified: 2009-03

Locations

US(1)