Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381485
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2006-09-26
Brief Title:
Effects of Mometasone FuroateFormoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics Study P04431AM2COMPLETED
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A 12-Week Efficacy and Safety Study of Two Doses of Mometasone FuroateFormoterol Combination Formulation Compared With Mometasone Furoate Monotherapy in Persistent Asthmatics Previously Treated With High-Dose Inhaled Glucocorticosteroids
Status:
COMPLETED
Status Verified Date:
2022-02
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:
This is a randomized multicenter double blind parallel-group study evaluating the efficacy of mometasone furoateformoterol fumarate MFF metered dose inhaler MDI 40010 mcg twice daily BID compared with MF MDI 400 mcg BID for 12 weeks Prior to the 12-week double-blind treatment period subjects will receive open-label MF MDI 400 mcg BID for 2 to 3 weeks during the run-in period Efficacy will be measured by the area under the curve from 0 to 12 hours AUC0-12 hr of the change from Baseline to the Week 12 Endpoint in forced expiratory volume in one second FEV1
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT No 2005-005910-20 | None | None | None |
| Doc ID 3166301 | None | None | None |