Dose-Ranging Study of A006 DPI, in Adult Asthma Patients
Completed · Phase 2 · Has a placebo group
Conditions studied: Asthma, Bronchospasm
In brief
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.
Key facts
- Study ID
- NCT01174732
- Run by
- Amphastar Pharmaceuticals, Inc.
- People needed
- 26
- Starts
- 2010-07-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2017-04-19
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- With mild-to-moderate persistent asthma for at least 6 months and having used inhaled beta-agonist for asthma control;
- Must demonstrate response to beta 2 agonist by Reversing;
- Must demonstrate ability to use DPI;
- Females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
- Additional Criteria
You may not qualify if…
- Smoking history of ≥ 10 pack-years, or having smoked within 6 months;
- Upper respiratory tract infections
- Asthma exacerbations;
- Known intolerance or hypersensitivity to any of the ingredients of the study drug or Proventil®;
- Use of prohibited drugs or failure to observe the drug washout restrictions;
- Having been on other clinical drug/device studies in the last 30 days;
- Other Criteria
Where it is running
- Amphastar Site 0001 — San Jose, California, United States
- Amphastar Site 0007 — Centennial, Colorado, United States
- Amphastar Site 0008 — Denver, Colorado, United States
- Amphastar Site 0039 — Lakewood, Colorado, United States
Full record on ClinicalTrials.gov
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