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NCT01606306 · ClinicalTrials.gov registry record · Phase 3
Individualized Therapy For Asthma in Toddlers
A Phase 3 study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
NCT01606306: Completed Phase 3 study, sponsored by Milton S. Hershey Medical Center.
NCT01606306 is a Phase 3 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01606306, a Phase 3 study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
Study 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.
Primary Outcome
The primary outcome was differential response to the three therapies on the basis of fixed threshold criteria for the following asthma control measures, which encompassed domains of risk and impairment: the time from the start of the treatment period to an asthma exacerbation treated with systemic corticosteroids, and the annualized number of asthma control days (ACDs) from within that period. ACDs were defined as full calendar days without symptoms, rescue medication use, or unscheduled healthc
Interventions
- DRUG Montelukast
- DRUG daily fluticasone propionate
- DRUG as-needed fluticasone propionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2013-02 |
| Est. Completion | 2015-04 |
| Phase | Phase 3 |
What the finished NCT01606306 record still lists
NCT01606306 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 3 interventions - of which Montelukast is the first listed.
NCT01606306 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01606306 about?
NCT01606306 is a clinical study titled "Individualized Therapy For Asthma in Toddlers". 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...
What is the current status of trial NCT01606306?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2013-02. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01606306?
The interventions under investigation include: Montelukast (DRUG), daily fluticasone propionate (DRUG), as-needed fluticasone propionate (DRUG).
Who is sponsoring clinical trial NCT01606306?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01606306's enrollment target sits among peer trials
300 1122nd of 2000 higher than 840 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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