CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 182 enrolled
Drug / intervention
fluticasone propionate + montelukast +2 moredrug
Likely dose
fluticasone propionate + montelukast 100 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00395304
NCT00395304Phase 3Completed
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Childhood Asthma Research and Education (CARE) Network Trial - Best Add-On Therapy Giving Effective Response (BADGER)

Milton S. Hershey Medical Center·interventional·Posted Nov 2, 2006·Updated Jul 2, 2018

In Brief

A Phase 3 clinical trial evaluating fluticasone propionate + montelukast, fluticasone propionate, and 1 other intervention for Asthma. Completed, enrolled 182 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2, 2006
Enrollment StartMar 1, 2007
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 19.7 years ago

Interventions

fluticasone propionate + montelukastdrug

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

fluticasone propionatedrug

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

fluticasone propionate + salmeteroldrug

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