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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00071552
• Other study ID #: IXR-402-4-196
• Status: Terminated
• Phase: Phase 4
• Start date: January 31, 2004
• Est. completion date: July 31, 2006

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: July 31, 2006
• Est. primary completion date: July 31, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
United States	National Jewish Medical and Research Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in post-inhalation percent-predicted FEF 25-75 (%) from baseline (week 0) to week 12		Final Visit
Secondary	Mean and mean change from pre-dose to 15-minute post-dose in percent predicted FEV1 (%) at week 12		week 12