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NCT01174732 · ClinicalTrials.gov registry record · Phase 2
Dose-Ranging Study of A006 DPI, in Adult Asthma Patients
A Phase 2 study, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT01174732: Completed Phase 2 study, sponsored by Amphastar Pharmaceuticals.
NCT01174732 is a Phase 2 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01174732, a Phase 2 study, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover and dose-ranging design. This study aims to evaluate the efficacy and initial safety profiles, and to identify the optimum dose of A006, from a select dose-range for future clinical PK/PD and Phase III studies. This study is to be conducted in generally healthy, adult subjects who have mild-to-moderate persistent asthma for at least 6 months prior to Screening.
Primary Outcome
Area under the curve (AUC) of post-dose FEV1 percentage changes from the Pre-dose Baseline. The primary analysis of the primary endpoint is to compare the AUC0-t of FEV1, between the A006 treatments and the Placebo Control.
Interventions
- DRUG Placebo
- DRUG albuterol inhalation powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
What the finished NCT01174732 record still lists
NCT01174732 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01174732 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01174732 about?
NCT01174732 is a clinical study titled "Dose-Ranging Study of A006 DPI, in Adult Asthma Patients". This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover and dose-ranging design. This study aims to evaluate the efficacy and initial safety profiles, and to identify the optimum dose of A006, from a select dose-range for future clinical PK/PD and Phase III stud...
What is the current status of trial NCT01174732?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2010-07. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01174732?
The interventions under investigation include: Placebo (DRUG), albuterol inhalation powder (DRUG).
Who is sponsoring clinical trial NCT01174732?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01174732's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 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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