Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094016
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2004-10-08
Brief Title:
Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children
Sponsor:
Teva Branded Pharmaceutical Products RD Inc
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to compare the QVAR-Easi-Breathe 100 mcgday and QVAR-Easi-Breathe 200 mcgday 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 ie QVAR-Easi-Breathe versus QVAR-MDI at the same dose levels
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None