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Childhood Asthma Research and Education (CARE) Network Trial - Best Add-On Therapy Giving Effective Response (BADGER)

NCT00395304 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 182

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. While a low dose of inhaled corticosteroids (ICS) may effectively control symptoms, some children may require additional medications to maintain adequate asthma control. This study compares the effectiveness of a higher dose of ICS, ICS combined with a long-acting beta-agonist (LABA) medication, and ICS combined with a leukotriene receptor antagonist (LTRA) medication at reducing the impact and severity of asthma exacerbations that occur in children with mild to moderate persistent asthma.

Conditions

Interventions

DRUG

fluticasone propionate + montelukast

Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)

DRUG

fluticasone propionate

Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)

DRUG

fluticasone propionate + salmeterol

Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)

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
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-03-31
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 NCT00395304 on ClinicalTrials.gov