CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
daily fluticasone propionate +2 moredrug
Likely dose
daily fluticasone propionate 44 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/NCT01606306
NCT01606306Phase 3Completed
CompareCT.gov

Individualized Therapy For Asthma in Toddlers

Milton S. Hershey Medical Center·interventional·Posted May 25, 2012·Updated Mar 16, 2017

In Brief

A Phase 3 clinical trial evaluating daily fluticasone propionate, Montelukast, and 1 other intervention for Asthma and Wheezing. Completed, enrolled 300 participants across 13 sites.

Detailed 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.

Study Details

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

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 25, 2012
Enrollment StartFeb 1, 2013
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.1 years ago

Interventions

daily fluticasone propionatedrug

Flovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily

Montelukastdrug

Singulair®, 4 mg granules or chewable tablets by mouth once daily in the evening

as-needed fluticasone propionatedrug

Flovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms