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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03022097 | Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients | PHASE3 | COMPLETED | 1,625 | — | — | Feb 2, 2017 | Apr 14, 2022 | Mar 26, 2025 | 74 | China, India +3 |
Change from baseline in 1-hour morning post-dose FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Aclidinium bromide at Week 24. Baseline was defined as the average of the two FEV1 values measure prior to the administration of the first dose of the IP at randomisation visit. If one of the two values was missing, the available one was used as baseline. If both values were missing, the screening pre-bronchodilator value was used. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Formoterol fumarate 12 μg at Week 24. Morning pre-dose (trough) FEV1 was defined as the average of the two FEV1 values at morning pre-dose of IP at Week 24. If one value was missing, the remaining was used as the trough value. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg compared to placebo at Week 24. Morning pre-dose (trough) FEV1 was defined as the average of the two FEV1 values at morning pre-dose of IP at Week 24. If one value was missing, the remaining was used as the trough value. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
| Arm | Type | Description |
|---|---|---|
| Experimental 1 | EXPERIMENTAL | Aclidinium bromide 400μg/Formoterol fumarate 12 μg |
| Experimental 2 | EXPERIMENTAL | Aclidinium bromide 400 μg |
| Comparator | ACTIVE_COMPARATOR | Formoterol fumarate 12 μg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Aclidinium bromide/formoterol Fixed-Dose Combination | DRUG | Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination, twice per day via Genuair |
| Aclidinium bromide | DRUG | Inhaled Aclidinium bromide 400 μg, twice per day via Genuair |
| Formoterol Fumarate | DRUG | Inhaled Formoterol Fumarate 12 μg, twice per day via Turbuhaler |
| Placebo | DRUG | Inhaled dose-matched placebo, twice per day via Genuair or via Turbuhaler |
Inclusion Criteria: * 1\. Adult male or non-pregnant, non-lactating female patients aged ≥40 * 2\. Patients with a diagnosis of COPD prior to Visit 1 (screening) * 3\. Patients with moderate to severe stable COPD (Stage II or Stage III) at Visit 1: post-bronchodilator FEV1 ≥30% and \< 80% and post-...