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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01078623 | Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate | PHASE2 | COMPLETED | 176 | — | — | Feb 1, 2010 | Sep 1, 2010 | Feb 23, 2017 | 10 | Czechia, Romania |
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose
| Arm | Type | Description |
|---|---|---|
| Formoterol 12 μg | ACTIVE_COMPARATOR | Formoterol fumarate 12 μg twice daily |
| Placebo | PLACEBO_COMPARATOR | Placebo twice daily |
| Aclidinium 200 μg / formoterol 12 μg | EXPERIMENTAL | Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily |
| Aclidinium 200 μg / formoterol 6 μg | EXPERIMENTAL | Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily |
| Aclidinium 200 μg | EXPERIMENTAL | Aclidinium bromide 200 μg twice daily |
| Name | Type | Description |
|---|---|---|
| Aclidinium 200 μg / formoterol 12 μg | DRUG | Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily |
| Placebo | DRUG | Placebo control twice daily |
| Formoterol 12 μg | DRUG | Formoterol fumarate 12 μg twice daily |
| Aclidinium 200 μg | DRUG | Aclidinium bromide 200 μg twice daily |
| Aclidinium 200 μg / Formoterol 6 μg | DRUG | Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily |
Inclusion Criteria: 1. Adult male or non-pregnant, non-lactating female aged between 40 and 80 years old, both inclusive. 2. Patient with a clinical diagnosis of stable moderate to severe COPD according to the GOLD classification 3. Current, or ex-cigarette smoker with a smoking history of at least...