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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00424008 | Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1) | PHASE3 | COMPLETED | 722 | — | — | Apr 1, 2007 | Nov 1, 2008 | May 20, 2024 | - | — |
| NCT00381485 | Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04431AM2)(COMPLETED) | PHASE3 | COMPLETED | 834 | — | — | Jul 1, 2006 | Jan 1, 2008 | May 20, 2024 | - | — |
| NCT00635882 | Asthma Study Comparing Anti-Inflammatory Effects of 3 Doses of Mometasone Furoate/Formoterol Fumarate and Medium Dose Mometasone Furoate (Study P05122 AM1)(COMPLETED) | PHASE2 | COMPLETED | 93 | — | — | Feb 1, 2008 | Jun 1, 2009 | May 14, 2024 | - | — |
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 versus MF. Standard deviation was pooled.
| Arm | Type | Description |
|---|---|---|
| MF/F MDI 200/10 mcg BID | EXPERIMENTAL | Mometasone furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily. |
| F/SC DPI 250/50 mcg BID | ACTIVE_COMPARATOR | Fluticasone propionate/salmeterol (F/SC) 250/50 mcg BID |
| MF/F MDI 400/10 mcg BID | EXPERIMENTAL | Mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period |
| MF MDI 400 mcg BID | ACTIVE_COMPARATOR | Mometasone Furoate 400 mcg taken twice daily Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period |
| MF/F MDI 100/10 mcg | EXPERIMENTAL | - |
| MF/F MDI 200/10 mcg | EXPERIMENTAL | - |
| MF/F MDI 400/10 mcg | EXPERIMENTAL | - |
| MF DPI 200 mcg | EXPERIMENTAL | - |
| MF MDI 200 mcg | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Mometasone furoate/formoterol (MF/F) MDI | DRUG | MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks. |
| Fluticasone propionate/salmeterol (F/SC) DPI | DRUG | Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks. |
| Mometasone furoate/formoterol (MF/F) combination | DRUG | MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks |
| Mometasone furoate MDI (MF MDI) | DRUG | MF 400 mcg via metered dose inhaler twice daily for 12 weeks |
| mometasone furoate/formoterol 100/10 mcg | DRUG | mometasone furoate/formoterol 100/10 mcg twice daily (BID) (two inhalations of MF/F 50/5 from a metered-dose inhaler) for 14 days |
| mometasone furoate/formoterol 200/10 mcg | DRUG | mometasone furoate/formoterol 200/10 mcg twice daily (BID) (two inhalations of MF/F 100/5 from a metered-dose inhaler) for 14 days |
| mometasone furoate/formoterol 400/10 mcg | DRUG | mometasone furoate/formoterol 400/10 mcg twice daily (BID) (two inhalations of MF/F 200/5 mcg from a metered-dose inhaler) for 14 days |
| MF DPI 200 mcg | DRUG | MF DPI 200 mcg twice daily (BID) (one inhalation of MF DPI 200 mcg) for 14 days |
| MF MDI 200 mcg | DRUG | MF MDI 200 mcg twice daily (BID) (two inhalations of MF MDI 100 mcg) for 14 days |
| Placebo | DRUG | MF/F MDI placebo twice daily (BID) (2 inhalations) |
Inclusion Criteria: * Participants must have a diagnosis of asthma for at least 12 months' duration. * A participant must have been using a medium daily dose of inhaled glucocorticosteroids (alone or in combination with long-acting beta 2-agonist \[LABA\]) for at least 12 weeks and must have been o...