NCT01606306

Individualized Therapy For Asthma in Toddlers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 12 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Detailed description

INFANT is a double-blind, randomized clinical trial in which all participants will receive each of the three therapies for 16 weeks by means of a cross-over study design. INFANT aims to determine whether individual children respond better to one treatment than another and, if so, whether those children can be identified by phenotypic characteristics or selected biomarkers. In this regard the INFANT study is expected to address critical gaps in current asthma management guidelines. Ultimately, the findings from this study are expected to help clarify treatment modalities for this population of young preschool children who are extremely difficult to treat.

Conditions

• Asthma
• Wheezing

Interventions

Type	Name	Description
DRUG	daily fluticasone propionate	Flovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily
DRUG	Montelukast	Singulair®, 4 mg granules or chewable tablets by mouth once daily in the evening
DRUG	as-needed fluticasone propionate	Flovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2012-05-25
• Last updated: 2017-03-16
• Results posted: 2017-03-16

Locations

13 sites across 1 country: United States