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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00383240 | Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED) | PHASE3 | COMPLETED | 781 | — | — | Sep 1, 2006 | Sep 1, 2008 | May 20, 2024 | - | — |
| NCT00383552 | Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)(COMPLETED) | PHASE3 | COMPLETED | 746 | — | — | Sep 1, 2006 | Aug 1, 2008 | May 17, 2024 | - | — |
This endpoint was to measure the time it took for 50% of subjects in a treatment arm to experience a severe asthma exacerbation (also see the posted Other Pre-specified Outcome: Number of Participants With at Least One Severe Asthma Exacerbation)
The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F vs MF. Standard deviation was pooled.
Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.
Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days and or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.
| Arm | Type | Description |
|---|---|---|
| MF/F MDI 200/10 mcg BID | EXPERIMENTAL | - |
| MF MDI 200 mcg BID | EXPERIMENTAL | - |
| F MDI 10 mcg BID | EXPERIMENTAL | - |
| Placebo BID | PLACEBO_COMPARATOR | - |
| MF/F MDI 100/10 mcg BID | EXPERIMENTAL | - |
| MF MDI 100 mcg BID | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID | DRUG | MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks |
| Mometasone furoate MDI (MF MDI) 200 mcg | DRUG | MF 200 mcg via metered dose inhaler twice daily for 26 weeks |
| formoterol fumarate 10 mcg | DRUG | F via metered dose inhaler 10 mcg twice a day for 26 weeks |
| Placebo | DRUG | Placebo metered dose inhaler twice a day for 26 weeks |
| Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID | DRUG | MF/F 100/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks |
| Mometasone Furoate MDI (MF MDI) | DRUG | MF 100 mcg via metered dose inhaler twice daily for 26 weeks |
Adult and adolescent subjects of either sex and any race, at least 12 years of age or older, with a diagnosis of asthma of at least 12 months' duration, will be eligible for enrollment. Subjects must meet all of the inclusion criteria and none of the exclusion criteria to receive treatment assignmen...