Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109668
Status:
COMPLETED
Last Update Posted:
2021-12-08
First Post:
2005-05-02
Brief Title:
Evaluation of Two Doses of QVAR Versus Placebo by Breath Operated and Metered Dose Inhalers in Moderate Asthmatic Adolescents and Adults on a Stable Regimen of Inhaled Corticosteroids
Sponsor:
Teva Branded Pharmaceutical Products RD Inc
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2021-12
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:
QVAR in a standard press and breath inhaler QVAR-MDI has been approved by the Food and Drug Administration FDA for use in the United States The purpose of this study is to determine the level of asthma control when comparing the safety and effectiveness of QVAR in two different devices a metered dose inhaler MDI and a breath operated inhaler BOI
Detailed Description:
This investigation is a multicenter randomized placebo and active controlled double-blind double-dummy parallel-group study to evaluate the safety and efficacy of two doses of QVAR-BOI in adolescents and adults
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