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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02796677 | AMPLIFY - D6571C00001 Duaklir USA Phase III Study | PHASE3 | COMPLETED | 1,595 | — | — | Jul 5, 2016 | Jun 8, 2017 | Nov 9, 2018 | 163 | United States, Bulgaria +8 |
To assess the bronchodilatory effect by evaluating the mean changes from baseline in FEV1 at 1 hour post-dose of AB/FF 400/12 µg compared to AB 400 μg after administration of oral inhalation powder BID via DIP to participants with COPD. Baseline was defined as the average of the two FEV1 values measured just prior to the administration of the first dose of investigational product (IP) at randomization Visit. If one of the two was missing, then the available one would be used as baseline value.
To assess the bronchodilatory effect by evaluating the mean changes from baseline in FEV1 in morning pre-dose (trough) of AB/FF 400/12 µg compared to FF 12 μg after administration of oral inhalation powder BID via DPI to participants with COPD. Morning pre-dose (trough) FEV1 was defined as the average of the corresponding -30 minute and 0 minute before the morning study medication at Week 24. If one time-point was missing then the available one would be used as morning pre-dose.
To assess the non-inferior bronchodilatory effect by evaluating the mean changes from baseline in FEV1 in morning pre-dose (trough)of AB 400 µg compared to TIO 18 μg after administration of oral inhalation powder BID via DPI to participants with COPD.
| Arm | Type | Description |
|---|---|---|
| AB/FF 400/12 μg BID | EXPERIMENTAL | Participants were administered AB/FF 400/12 μg via Pressair®/Genuair® inhaler twice daily for 24 weeks of treatment. |
| AB 400 μg BID | EXPERIMENTAL | Participants were administered AB 400 μg via Pressair®/Genuair® inhaler twice daily for 24 weeks of treatment. |
| FF 12 μg BID | EXPERIMENTAL | Participants were administered FF 12 μg via Pressair®/Genuair® inhaler twice daily for 24 weeks of treatment. |
| TIO 18 μg QD | EXPERIMENTAL | Participants were administered TIO 18 μg via Handihaler® inhale once daily for 24 weeks of treatment. |
| Name | Type | Description |
|---|---|---|
| Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg) | DRUG | Inhalation powder |
| Aclidinium bromide 400 μg (AB 400 μg) | DRUG | Inhalation powder |
| Formoterol fumarate 12 μg (FF 12 μg) | DRUG | Inhalation powder |
| Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg | OTHER | Inhalation powder |
| Tiotropium 18 μg (TIO 18 μg) | DRUG | Powder in capsules for oral inhalation |
| Placebo to TIO 18 μg | OTHER | Powder in capsules for oral inhalation |
Inclusion Criteria: * Adult male or non-pregnant, non-lactating female patients aged ≥40. * Patients with diagnosis of moderate to very severe stable COPD: post-bronchodilator FEV1 \< 80% of the predicted normal and post-bronchodilator FEV1/FVC \< 70% at Screening Visit. * Symptomatic patients with...