Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children
Status:
Completed
Trial end date:
2006-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc. Teva Branded Pharmaceutical Products, R&D Inc.