drugset / Trial / NCT01606306
Individualized Therapy For Asthma in Toddlers
Phase 3
Completed
300 enrolled
Milton S. Hershey Medical Center
National Heart, Lung, and Blood Institute (NHLBI) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone propionate | Other / unclassified | 88 ug | Inhaled |
| Subject | Montelukast | Other / unclassified | 4 mg | Oral |