Status:
COMPLETED
Dose-Ranging Study of A006 DPI, in Adult Asthma Patients
Lead Sponsor:
Amphastar Pharmaceuticals, Inc.
Conditions:
Asthma
Bronchospasm
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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 iden...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01174732
Start Date
July 1 2010
End Date
January 1 2011
Last Update
April 19 2017
Active Locations (4)
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1
Amphastar Site 0001
San Jose, California, United States, 95117
2
Amphastar Site 0007
Centennial, Colorado, United States, 80112
3
Amphastar Site 0008
Denver, Colorado, United States, 80230
4
Amphastar Site 0039
Lakewood, Colorado, United States, 80401