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NCT01581177 · ClinicalTrials.gov registry record · Phase 2
Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation
A Phase 2 study, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT01581177: Completed Phase 2 study, sponsored by Amphastar Pharmaceuticals.
NCT01581177 is a Phase 2 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01581177, a Phase 2 study, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control. This study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma for at least 6 months, but are otherwise generally healthy.
Primary Outcome
Serial FEV1 measurements to demonstrate the mean AUC change in percent FEV1 from same-day baseline of A006 versus placebo control
Interventions
- DRUG Placebo DPI
- DRUG Albuterol DPI 25 mcg/inh
- DRUG Albuterol DPI 90 mcg/inh
- DRUG Albuterol MDI 90 mcg/inh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2012-04 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
What the finished NCT01581177 record still lists
NCT01581177 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo DPI is the first listed.
NCT01581177 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01581177 about?
NCT01581177 is a clinical study titled "Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation". The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control. Thi...
What is the current status of trial NCT01581177?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2012-04. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01581177?
The interventions under investigation include: Placebo DPI (DRUG), Albuterol DPI 25 mcg/inh (DRUG), Albuterol DPI 90 mcg/inh (DRUG), Albuterol MDI 90 mcg/inh (DRUG).
Who is sponsoring clinical trial NCT01581177?
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 NCT01581177's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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