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NCT01899144 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients
A Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT01899144: Completed Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01899144 is a Phase 2 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01899144, a Phase 2 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, single-dose, 5-treatment, 5-period, 5-way crossover study in pediatric patients with persistent asthma. The primary purpose of this study is to compare the efficacy and safety of Albuterol Spiromax with that of ProAir HFA in pediatric asthma patients at 2 delivered dose levels equivalent to 90 mcg and 180 mcg of albuterol base.
Primary Outcome
Percent predicted FEV1: measured FEV1 as a percent of the "predicted values" for the patients of similar characteristics. Predicted FEV1 values were computed and adjusted for age, height, and gender for patients aged 4-5 years (Eigen et al 2001) and for patients aged 6-11 years (Quanjer et al 1995) using ATS/European Thoracic Society (ERS) criteria applicable to pediatric patients (ATS/ERS 2007). The percent predicted FEV1 (PPFEV1) area under the curve (AUC)0-6 was calculated using the linear t
Interventions
- DRUG Placebo
- DRUG ProAir HFA
- DRUG Albuterol Spiromax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2013-07 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
What the finished NCT01899144 record still lists
NCT01899144 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01899144 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01899144 about?
NCT01899144 is a clinical study titled "Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients". This is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, single-dose, 5-treatment, 5-period, 5-way crossover study in pediatric patients with persistent asthma. The primary purpose of this study is to compare the efficacy and safety of Albuterol Spiromax with that of ProAir...
What is the current status of trial NCT01899144?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2013-07. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01899144?
The interventions under investigation include: Placebo (DRUG), ProAir HFA (DRUG), Albuterol Spiromax (DRUG).
Who is sponsoring clinical trial NCT01899144?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01899144's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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