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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00071552

Enrollment

Registered

2003-10-29

Start date

2004-01-31

Completion date

2006-07-31

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Poorly Controlled Asthma

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.

Interventions

DRUGQvar

Qvar (HFA-propelled beclomethasone dipropionate metered dose inhaler) 160 mcg twice daily for 12 weeks

DRUGFlovent Diskus

Flovent Diskus (fluticasone propionate multi-dose dry powder inhaler) 200 mcg twice daily for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026