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NCT01791972 · ClinicalTrials.gov registry record · Phase 3
Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 38
- Enrollment target
NCT01791972: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01791972 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 38 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01791972, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 38 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of a single dose (2 inhalations, 180 mcg total) of Albuterol SPIROMAX (90 mcg per inhalation) versus placebo in patients with EIB.
Primary Outcome
A centralized spirometry data collection system was used to reduce FEV1 variability between and within patients and between each participating study center. The percentage fall was defined as 100\*(baseline-post baseline)/baseline. The baseline FEV1 is the test day FEV1 measured 5 minutes before the exercise challenge (30 minutes postdose). FEV1 post exercise challenge were measured 5 (±5), 10 (±5), 15 (±5), 30 (±5), and 60 (±10) minutes after completion of the exercise challenge. The exercise
Interventions
- DRUG Albuterol Spiromax
- DRUG Placebo Spiromax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2013-03 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT01791972 record still lists
NCT01791972 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Albuterol Spiromax is the first listed.
NCT01791972 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01791972 about?
NCT01791972 is a clinical study titled "Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)". The primary objective of this study is to evaluate the efficacy of a single dose (2 inhalations, 180 mcg total) of Albuterol SPIROMAX (90 mcg per inhalation) versus placebo in patients with EIB.
What is the current status of trial NCT01791972?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2013-03. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01791972?
The interventions under investigation include: Albuterol Spiromax (DRUG), Placebo Spiromax (DRUG).
Who is sponsoring clinical trial NCT01791972?
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 NCT01791972's enrollment target sits among peer trials
38 1900th of 2000 higher than 100 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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