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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02571777 | Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma | PHASE3 | COMPLETED | 3,092 | — | — | Dec 8, 2015 | Jun 14, 2019 | Jul 22, 2020 | 403 | Argentina, Austria +39 |
| NCT03063086 | Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma. | PHASE2 | COMPLETED | 116 | — | — | Jan 21, 2017 | Aug 2, 2018 | Oct 4, 2021 | 12 | Bulgaria, China +4 |
Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The primary endpoint considered the following 2 comparison groups: * QVM149 150/50/80 μg o.d. compared with QMF149 150/160 μg o.d. both delivered via Concept1 * QVM149 150/50/160 μg o.d. compared with QMF149 150/320 μg o.d. both delivered via Concept1.
The highest bronchodilator effect on FEV1 during a period of 5 min to 4 h after the last evening dose of each treatment period . To demonstrate superiority in peak bronchodilator effect of QVM149 at a dose of 150/50/160 μg o.d. and 150/50/80 μg o.d. compared to a FDC of salmeterol/fluticasone at a dose of 50/500 μg b.i.d. after 3 weeks of treatment in patients with asthma
| Arm | Type | Description |
|---|---|---|
| QVM149 150/50/160 µg o.d. | EXPERIMENTAL | QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device |
| QVM149 150/50/80 µg o.d. | EXPERIMENTAL | QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device |
| QMF149 150/320 µg o.d. | ACTIVE_COMPARATOR | QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device |
| QMF149 150/160 µg o.d. | ACTIVE_COMPARATOR | QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device |
| Salmeterol/fluticasone 50/500 μg b.i.d. | ACTIVE_COMPARATOR | Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler® |
| Sequence 1 | ACTIVE_COMPARATOR | A-B-C |
| Sequence 2 | ACTIVE_COMPARATOR | A-C-B |
| Sequence 3 | ACTIVE_COMPARATOR | B-C-A |
| Sequence 4 | ACTIVE_COMPARATOR | B-A-C |
| Sequence 5 | ACTIVE_COMPARATOR | C-A-B |
| Sequence 6 | ACTIVE_COMPARATOR | C-B-A |
| Name | Type | Description |
|---|---|---|
| QVM149 150/50/160 | DRUG | - |
| QVM149 150/50/80 | DRUG | - |
| QMF149 150/320 | DRUG | - |
| QMF149 150/160 | DRUG | - |
| salmeterol/fluticasone | DRUG | - |
| QVM149 150/50/80 μg o.d. | DRUG | A |
| QVM149 150/50/160 μg o.d. | DRUG | B |
| salmeterol/fluticasone FDC 50/500 μg b.i.d. | DRUG | C |
Inclusion Criteria: * Patients with a diagnosis of asthma, (GINA 2015) for a period of at least 1 year prior to Visit 1 (Screening). * Patients who have used medium or high dose of ICS/LABA combinations for asthma for at least 3 months and at stable medium or high doses of ICS/LABA for at least 1 m...