Efficacy of QVAR vs Flovent Diskus on Small Airways in Poorly Controlled Asthmatic Adolescents/Adult Patients
This study has been terminated.
(Very poor enrollment)
Information provided by:
Teva Pharmaceutical Industries
First received: October 28, 2003
Last updated: May 9, 2014
Last verified: May 2014
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 poorly controlled asthmatics.
Drug: Flovent Diskus
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Evaluation of Clinical Efficacy of HFA-Propelled Beclomethasone Dipropionate Metered-Dose Inhaler Versus Fluticasone Propionate Multidose Dry Powder Inhaler on Small Airways in Poorly Controlled Asthmatic Adolescent and Adult Patients
Primary Outcome Measures:
- Change in post-inhalation percent-predicted FEF 25-75 (%) from baseline (week 0) to week 12 [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean and mean change from pre-dose to 15-minute post-dose in percent predicted FEV1 (%) at week 12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2006 (Final data collection date for primary outcome measure)
Qvar 160 mcg twice daily
Qvar (HFA-propelled beclomethasone dipropionate metered dose inhaler) 160 mcg twice daily for 12 weeks
Active Comparator: Flovent Diskus
Flovent Diskus 200 mcg twice daily
Drug: Flovent Diskus
Flovent Diskus (fluticasone propionate multi-dose dry powder inhaler) 200 mcg twice daily for 12 weeks
|Ages Eligible for Study:
||12 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00071552
|National Jewish Medical and Research Center
|Denver, Colorado, United States, 80206 |
Teva Branded Pharmaceutical Products, R&D Inc.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 28, 2003
||May 9, 2014
||United States: Institutional Review Board
Keywords provided by Teva Pharmaceutical Industries:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 31, 2014
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Respiratory System Agents
Peripheral Nervous System Agents