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

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00071552
Collaborator
(none)
49
Enrollment
1
Location
2
Arms
30
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 31, 2004
Actual Primary Completion Date :
Jul 31, 2006
Actual Study Completion Date :
Jul 31, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Qvar

Qvar 160 mcg twice daily

Drug: Qvar
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

Outcome Measures

Primary Outcome Measures

  1. Change in post-inhalation percent-predicted FEF 25-75 (%) from baseline (week 0) to week 12 [Final Visit]

Secondary Outcome Measures

  1. Mean and mean change from pre-dose to 15-minute post-dose in percent predicted FEV1 (%) at week 12 [week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Jewish Medical and Research Center Denver Colorado United States 80206

Sponsors and Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier:
NCT00071552
Other Study ID Numbers:
  • IXR-402-4-196
First Posted:
Oct 29, 2003
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.
Poorly Controlled Asthma
Additional relevant MeSH terms:
Asthma
Fluticasone
Xhance

Study Results

No Results Posted as of Nov 24, 2021