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NCT02126839 · ClinicalTrials.gov registry record · Phase 3
A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 186
- Enrollment target
NCT02126839: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT02126839 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 186 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02126839, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 186 participants
- Enrollment target
Study Summary
The study is to evaluate the chronic-dose efficacy and the safety of Albuterol MDPI compared to placebo in pediatric participants with asthma.
Primary Outcome
Following measurement of the baseline FEV1 and dose administration on Days 1 and 22, FEV1 values (highest of 3 acceptable maneuvers) will be obtained at 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±10), 120 (±10), 240 (±10), and 360 (±10) minutes after the completion of dosing. Predicted FEV1 values were computed and adjusted for age, height, and gender according to Eigen et al (Eigen et al 2001) for participants 4 to 5 years of age and to Quanjer et al (Quanjer et al 1995) for participants aged 6 to
Interventions
- DRUG Placebo
- DRUG Albuterol MDPI
- DRUG ProAir HFA inhaler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
What the finished NCT02126839 record still lists
NCT02126839 is an interventional study that assigns participants to a tested intervention. The registered 186 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 (76% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02126839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02126839 about?
NCT02126839 is a clinical study titled "A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics". The study is to evaluate the chronic-dose efficacy and the safety of Albuterol MDPI compared to placebo in pediatric participants with asthma.
What is the current status of trial NCT02126839?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 186 participants. The study started on 2014-05. Estimated completion is 2015-02.
What interventions are being tested in trial NCT02126839?
The interventions under investigation include: Placebo (DRUG), Albuterol MDPI (DRUG), ProAir HFA inhaler (DRUG).
Who is sponsoring clinical trial NCT02126839?
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 NCT02126839's enrollment target sits among peer trials
186 1412th of 2000 higher than 584 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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