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NCT01641081 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 174
- Enrollment target
NCT01641081: Completed Phase 2 study, sponsored by AstraZeneca.
NCT01641081 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 174 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01641081, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 174 participants
- Enrollment target
Study Summary
The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma. This study will include a screening visit followed by a 4 month treatment period.
Primary Outcome
AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of each treatment period The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals
Interventions
- DRUG Placebo
- DRUG Formoterol Fumarate in the Pressair DPI, Low Dose
- DRUG Formoterol Fumarate in the Pressair DPI, High Dose
- DRUG Foradil Aerolizer, Low Dose
- DRUG Foradil Aerolizer, High Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-02 |
| Phase | Phase 2 |
What the finished NCT01641081 record still lists
NCT01641081 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01641081 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01641081 about?
NCT01641081 is a clinical study titled "Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma". The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma. This study will include a screening visit followed by a 4 month treatment period.
What is the current status of trial NCT01641081?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 174 participants. The study started on 2012-06. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01641081?
The interventions under investigation include: Placebo (DRUG), Formoterol Fumarate in the Pressair DPI, Low Dose (DRUG), Formoterol Fumarate in the Pressair DPI, High Dose (DRUG), Foradil Aerolizer, Low Dose (DRUG), Foradil Aerolizer, High Dose (DRUG).
Who is sponsoring clinical trial NCT01641081?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01641081's enrollment target sits among peer trials
174 396th of 2000 higher than 1,604 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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