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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 31, 2006

Interventions

  • Drug: Qvar
    • Qvar (HFA-propelled beclomethasone dipropionate metered dose inhaler) 160 mcg twice daily for 12 weeks
  • Drug: Flovent Diskus
    • Flovent Diskus (fluticasone propionate multi-dose dry powder inhaler) 200 mcg twice daily for 12 weeks

Arms, Groups and Cohorts

  • Experimental: Qvar
    • Qvar 160 mcg twice daily
  • Active Comparator: Flovent Diskus
    • Flovent Diskus 200 mcg twice daily

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Teva Branded Pharmaceutical Products R&D, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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