Efficacy of QVAR vs Flovent Diskus on Small Airways in Poorly Controlled Asthmatic Adolescents/Adult Patients

Phase 4

Terminated

• Conditions: Asthma
• Interventions: Drug: Flovent Diskus; Drug: Qvar

• Registration Number: NCT00071552
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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 poorly controlled asthmatics.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-10-28
• Study First Submitted QC: 2003-10-28
• Study First Posted: 2003-10-29
• Study Start: 2004-01-31
• Primary Completion: 2006-07-31
• Study Completion: 2006-07-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flovent Diskus	Flovent Diskus	Flovent Diskus 200 mcg twice daily
Qvar	Qvar	Qvar 160 mcg twice daily

Primary Outcome Measures

Name	Time	Method
Change in post-inhalation percent-predicted FEF 25-75 (%) from baseline (week 0) to week 12	Final Visit

Secondary Outcome Measures

Name	Time	Method
Mean and mean change from pre-dose to 15-minute post-dose in percent predicted FEV1 (%) at week 12	week 12

Trial Locations

Locations (1)

National Jewish Medical and Research Center; 🇺🇸 Denver, Colorado, United States