Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00383240
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2006-09-29
Brief Title:
Effects of Mometasone FuroateFormoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics Study P04334AM1COMPLETED
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A 26-Week Placebo-Controlled Efficacy and Safety Study of Mometasone FuroateFormoterol Fumarate Combination Formulation Compared With Mometasone Furoate and Formoterol Monotherapy in Subjects With Persistent Asthma Previously Treated With Medium-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 multi-center double-blind double-dummy placebo-controlled parallel-group study evaluating the efficacy of mometasone furoate MF formoterol fumarate FMFF metered dose inhaler MDI versus MF for 26 weeks Prior to the 26-week double-blind Treatment Period subjects will receive open-label MF MDI 200 mcg twice daily 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 hours of the Change From Baseline to the Week 12 Endpoint
in Forced Expiratory Volume in One Second FEV1 Time Frame Baseline to Week 12 and Time-to-First Severe Asthma Exacerbation across the 26-week treatment period
in Forced Expiratory Volume in One Second FEV1 Time Frame Baseline to Week 12 and Time-to-First Severe Asthma Exacerbation across the 26-week treatment period
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 2006-001578-25 | None | None | None |