drugset / Trial / NCT01606306

Individualized Therapy For Asthma in Toddlers

NCT01606306

RandomizedCrossoverQuadruple-blindTreatment

Summary

The INFANT study will test whether, in preschool children 12-59 months of age with persistent asthma, the following Step 2 asthma therapies will provide similar degrees of asthma control: 1. Daily inhaled corticosteroid (ICS) treatment, 2. Daily leukotriene receptor antagonist (LTRA) treatment, and 3. As-needed ICS plus short-acting beta agonist (as-needed ICS/SABA) rescue treatment.

Timeline

Start
2013-02
Primary completion
2015-04
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone propionate Other / unclassified 88 ug Inhaled
Subject Montelukast Other / unclassified 4 mg Oral

Indications