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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04072887 | Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients | PHASE2 | COMPLETED | 974 | — | — | Sep 12, 2019 | Feb 1, 2022 | Apr 28, 2023 | 148 | United States, Argentina +24 |
The primary efficacy analysis assessed the effect of QBW251 on the absolute change from baseline in trough FEV1 in liters on Week 12. Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline measurement was defined as the baseline visit pre-bronchodilator spirometry assessment. Change from baseline in the FEV1 mean scores were analyzed using a Mixed Model for Repeated Measures (MMRM): treatment + baseline score + smoking status at screening + run-in FEV1 + airflow limitation severity + region + time interval + treatment\*time interval interaction + baseline score\*time interval interaction.
| Arm | Type | Description |
|---|---|---|
| QBW251 450 mg | EXPERIMENTAL | QBW251 was orally administered 450 mg b.i.d for 24 weeks |
| QBW251 300 mg | EXPERIMENTAL | QBW251 was orally administered 300 mg b.i.d for 24 weeks |
| QBW251 150 mg | EXPERIMENTAL | QBW251 was orally administered 150 mg b.i.d for 24 weeks |
| QBW251 75 mg | EXPERIMENTAL | QBW251 was orally administered 75 mg b.i.d for 24 weeks |
| QBW251 25 mg | EXPERIMENTAL | QBW251 was orally administered 25 mg b.i.d for 24 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo was orally administered b.i.d for 24 weeks |
| Name | Type | Description |
|---|---|---|
| QBW251 | DRUG | QBW251 oral capsules (450, 300, 150, 75 and 25 mg) of identical appearance to ensure blinding administered twice a day (b.i.d) for 24 weeks |
| Placebo | DRUG | Placebo oral capsules administered twice a day for 24 weeks |
| COPD maintenance background therapy | DRUG | Combination of fluticasone furoate, vilanterol and umeclidinium bromide |
Inclusion Criteria: * Male and female COPD patients aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure. * Current or ex-smokers who have a smoking history of at least 10 pack years. * Patients who have been treated with a triple combination o...