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Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children

Asthma Clinical Trial

Official title:
Safety and Efficacy Evaluation of Two Doses of HFA-Propelled Beclomethasone Dipropionate (QVAR) Versus Placebo by Breath Operated and Metered Dose Inhalers in Mild to Moderate Asthmatic Children

Clinical Trial Summary

The primary objective of this study is to compare the QVAR-Easi-Breathe 100 mcg/day and QVAR-Easi-Breathe 200 mcg/day with placebo relative to changes in forced expiratory volume in 1 second (FEV1) results following 12 weeks of treatment. Secondary objectives such as daily asthma symptoms scores (per week), morning peak expiratory flow (PEF) values, nocturnal awakening and utilization of rescue medication per day also will be evaluated. In addition, an exploratory evaluation will assess the comparability of the two devices (i.e., QVAR-Easi-Breathe versus QVAR-MDI) at the same dose levels.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00094016
Study type Interventional
Source Teva Branded Pharmaceutical Products R&D, Inc.
Contact
Status Completed
Phase Phase 3
Start date October 31, 2004
Completion date June 30, 2006
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