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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00071552
Recruitment Status : Terminated (Very poor enrollment)
First Posted : October 29, 2003
Last Update Posted : May 12, 2014
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

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
Asthma Drug: Qvar Drug: Flovent Diskus Phase 4

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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : January 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006


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




Primary Outcome Measures :
  1. Change in post-inhalation percent-predicted FEF 25-75 (%) from baseline (week 0) to week 12 [ Time Frame: 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 [ Time Frame: week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00071552


Locations
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United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
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ClinicalTrials.gov Identifier: NCT00071552    
Other Study ID Numbers: IXR-402-4-196
First Posted: October 29, 2003    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: May 2014
Keywords provided by Teva Pharmaceutical Industries:
Poorly Controlled Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents