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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00941798 | Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma | PHASE2 | COMPLETED | 2,283 | — | — | Jul 1, 2009 | May 1, 2011 | Aug 31, 2012 | 146 | United States, Brazil +7 |
Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.
| Arm | Type | Description |
|---|---|---|
| QMF149 Twisthaler® 500/400 | EXPERIMENTAL | QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD) |
| Mometasone Twisthaler® | ACTIVE_COMPARATOR | Mometasone Twisthaler®, 400 µg QD |
| Name | Type | Description |
|---|---|---|
| QMF149 Twisthaler® | DRUG | Once daily via multi-dose dry-powder inhaler |
| Mometasone Twisthaler® | DRUG | Once daily via multi-dose dry-powder inhaler |
Inclusion Criteria: * Patients with a documented diagnosis of persistent asthma and who were currently treated with or qualified for treatment with both ICS and long-acting beta2-agonist (LABA) combination * Patients demonstrating an increase in forced expiration volume in 1 second (FEV1) of ≥ 12% ...