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(CARE Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA)

NCT00394329 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2018-07-02

Study results available
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Summary

Asthma is a common, serious illness among children in the United States. It can be effectively controlled through the use of preventative medications and "rescue" medications, which are used to control symptoms. This study will evaluate the impact and severity of asthma exacerbations that occur in children with mild persistent asthma who are receiving various combinations of medications for daily and rescue use.

Conditions

Interventions

DRUG

Beclomethasone dipropionate

Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid

DRUG

Beclomethasone dipropionate

Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed

DRUG

Albuterol sulfate

Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed

Sponsors & Collaborators

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

    collaborator NIH

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • David T. Mauger, PhD · Penn State College of Medicine

  • Stanley J. Szefler, MD, PhD · National Jewish Health

  • Robert F. Lemanske, Jr., MD · University of Wisconsin, Madison

  • Robert S. Zeiger, MD, PhD · Kaiser Permanente Medical Center

  • Robert C. Strunk, MD · Washington University School of Medicine

  • Fernando D. Martinez, MD · University of Arizona College of Medicine

  • Lynn M. Taussig, MD · University of Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00394329 on ClinicalTrials.gov