Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00383435
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2006-09-29
Brief Title:
Effects of Mometasone FuroateFormoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD Study P04229AM4COMPLETED
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A Randomized 26-Week Placebo-Controlled Efficacy and Safety Study With a 26-Week Long-Term Safety Extension of High- and Medium-Dose Inhaled Mometasone FuroateFormoterol Fixed-Dose Combination Formulation Compared With Formoterol and High-Dose Inhaled Mometasone Furoate Monotherapy in Subjects With Moderate to Severe COPD
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 placebo-controlled parallel-group multi-site double-blind study evaluating the efficacy of mometasone furoateformoterol fumarate MFF metered dose inhaler MDI 40010 mcg twice daily BID and MFF MDI 20010 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years of age with moderate to severe chronic obstructive pulmonary disease COPD All placebo-treated subjects and active-treated
subjects who will not participate in the safety extension will be discontinued
and will have their Final Visit at Week 26 Subjects who continue into the
26-week safety extension will have their Final Visit at Week 52 Efficacy will be measured by the mean change from Baseline to Week 13 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours FEV1 AUC0-12hr and change from Baseline to Week 13 in AM predose FEV1
subjects who will not participate in the safety extension will be discontinued
and will have their Final Visit at Week 26 Subjects who continue into the
26-week safety extension will have their Final Visit at Week 52 Efficacy will be measured by the mean change from Baseline to Week 13 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours FEV1 AUC0-12hr and change from Baseline to Week 13 in AM predose 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 2006-002308-32 | None | None | None |
| Doc ID 3227334 | None | None | None |