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NCT01189396 · ClinicalTrials.gov registry record · Phase 2
Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006
A Phase 2 study, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT01189396: Completed Phase 2 study, sponsored by Amphastar Pharmaceuticals.
NCT01189396 is a Phase 2 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 27 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
NCT01189396, a Phase 2 study, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in escalating and cumulative-doses up to 1440 mcg, eight (8) times of the proposed clinical dose.
Primary Outcome
Area Under the Curve (AUC)0-t of percent change in Forced Expiratory Volume in 1 second (FEV1), which is defined as the area under curve of post-dose FEV1 percentage changes from the Pre-dose Baseline FEV1 (FEV10) versus time. Doses are at 0, 30, 60 and 90 min.
Interventions
- DRUG Placebo DPI
- DRUG A006
- DRUG Proventil-HFA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
What the finished NCT01189396 record still lists
NCT01189396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 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 3 interventions - of which Placebo DPI is the first listed.
NCT01189396 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01189396 about?
NCT01189396 is a clinical study titled "Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006". The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in escalating and cumulative-doses ...
What is the current status of trial NCT01189396?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2010-07. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01189396?
The interventions under investigation include: Placebo DPI (DRUG), A006 (DRUG), Proventil-HFA (DRUG).
Who is sponsoring clinical trial NCT01189396?
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 NCT01189396's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 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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