Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00383435 | Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED) | PHASE3 | COMPLETED | 1,055 | — | — | Oct 1, 2006 | Jul 1, 2010 | May 20, 2024 | - | — |
| NCT00383721 | Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in Chronic Obstructive Pulmonary Disease (COPD) (Study P04230AM4)(COMPLETED) | PHASE3 | COMPLETED | 1,196 | — | — | Sep 1, 2006 | Jul 1, 2010 | May 23, 2024 | - | — |
FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward.
Endpoint was the last post-baseline non-missing result through Week 13 carried forward.
| Arm | Type | Description |
|---|---|---|
| MF/F MDI 400/10 mcg BID | EXPERIMENTAL | - |
| MF/F MDI 200/10 mcg BID | EXPERIMENTAL | - |
| MF MDI 400 mcg BID | EXPERIMENTAL | - |
| Formoterol MDI 10 mcg BID | ACTIVE_COMPARATOR | - |
| Placebo MDI BID | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Mometasone furoate/formoterol (MF/F) combination | DRUG | MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks |
| Mometasone furoate MDI (MF MDI) | DRUG | MF 400 mcg via metered dose inhaler twice daily for 52 weeks |
| Formoterol MDI | DRUG | Formoterol 10 mcg via metered dose inhaler twice a day for 52 weeks |
| Placebo | DRUG | Placebo MDI twice a day for 26 weeks |
Inclusion Criteria: * Moderate to severe COPD based on prebronchodilator FEV1/forced vital capacity (FVC) ratio of \<=70%. * At Screening, postbronchodilator FEV1 must be \<=60% predicted normal \& \>=25% predicted normal. * COPD symptoms for \>=24 months. * Ex- or current smoker with smoking histo...