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NCT02210806 · ClinicalTrials.gov registry record · Phase 2
Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation
A Phase 2 study of Asthma, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 4
- Study locations
NCT02210806: Completed Phase 2 study of Asthma, sponsored by Amphastar Pharmaceuticals.
NCT02210806 is a Phase 2 study of Asthma that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 22 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02210806, a Phase 2 study of Asthma, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study evaluates the efficacy, dose-ranging and safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 110 to 220 mcg per dose in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.
Primary Outcome
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Area under the curve (AUC), from baseline to 6 hours post-dose, for the treatment period is calculated using the trapezoidal rule. Statistical analysis is performed using a one-sided t-test.
Conditions Studied
Interventions
- DRUG A006 DPI
- OTHER Placebo DPI
- DRUG Proventil® MDI
Study Locations (4)
Texas
- Amphastar Site 0030 - New Braunfels
- Amphastar Site 0032 - San Antonio
California
- Amphastar Site 0001 - San Jose
Oregon
- Amphastar Site 0025 - Medford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2014-07 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT02210806 record still lists
NCT02210806 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 3 interventions - of which A006 DPI is the first listed.
NCT02210806 reports a single indexed study location in Texas, California, Oregon.
Frequently Asked Questions
What is clinical trial NCT02210806 about?
NCT02210806 is a clinical study titled "Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation". This study evaluates the efficacy, dose-ranging and safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 110 to 220 mcg per dose in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.
What is the current status of trial NCT02210806?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2014-07. Estimated completion is 2014-10.
What conditions does trial NCT02210806 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT02210806?
The interventions under investigation include: A006 DPI (DRUG), Placebo DPI (OTHER), Proventil® MDI (DRUG).
Who is sponsoring clinical trial NCT02210806?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02210806 being conducted?
This trial has 4 study locations across California, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02210806's enrollment target sits among peer trials
22 332nd of 374 higher than 39 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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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