Status:
TERMINATED
Efficacy of QVAR vs Flovent Diskus on Small Airways in Poorly Controlled Asthmatic Adolescents/Adult Patients
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Asthma
Eligibility:
All Genders
12-70 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to evaluate the effect of Beclomethasone dipropionate HFA on small airways compared to Fluticasone propionate powder for inhalation administered twice daily to p...
Eligibility Criteria
Inclusion
- Poorly controlled asthma;
- Average use of over 2 puffs of albuterol per day in the previous 7 days OR Having symptoms of asthma on 5 of the last 7 days OR Awakening at night due to asthma at least once in the previous 7 days OR Having been treated with a course of oral or intravenous steroids at least once in the last 3 months.
Exclusion
- Subjects receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy for rhinitis;
- Requires beta-blockers, MAO inhibitors, tricyclic antidepressants, oral or intranasal anticholinergics;
- History and/or presence of any non-asthmatic acute or chronic lung disease, including but not limited to bronchitis, emphysema, active tuberculosis, bronchiectasis or cystic fibrosis;
- History and/or presence of any clinically significant cardiovascular disease, clinically significant hepatic, renal, or endocrine dysfunction, stroke, uncontrolled diabetes, hyperthyroidism, convulsive disorders, neoplastic disease other than basal cell carcinoma, and significant psychiatric disease.
Key Trial Info
Start Date :
January 31 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2006
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00071552
Start Date
January 31 2004
End Date
July 31 2006
Last Update
November 24 2021
Active Locations (1)
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1
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206