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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01049360 | Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo | PHASE2 | COMPLETED | 128 | — | — | Dec 1, 2009 | Aug 1, 2010 | Feb 28, 2017 | 20 | United States |
| Arm | Type | Description |
|---|---|---|
| Aclidinium 400 μg / Formoterol 12 μg | EXPERIMENTAL | Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) |
| Aclidinium 400 μg / formoterol 6 μg | EXPERIMENTAL | Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) |
| Aclidinium 400 μg | EXPERIMENTAL | Aclidinium bromide 400 μg administered twice-daily (BID) |
| Formoterol 12 μg | ACTIVE_COMPARATOR | Formoterol fumarate 12 μg twice-daily |
| Placebo | PLACEBO_COMPARATOR | Placebo twice-daily |
| Name | Type | Description |
|---|---|---|
| Aclidinium 400 μg / Formoterol 12 μg | DRUG | Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods. |
| Aclidinium 400 μg / Formoterol 6 μg | DRUG | Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods. |
| Aclidinium 400 μg | DRUG | Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods. |
| Formoterol 12 μg | DRUG | Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods. |
| Placebo | DRUG | Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods. |
Inclusion Criteria: * Understand the study procedures and be willing to participate in the study as indicated by signing the ICF and HIPAA form * Be male or female aged 40 to 80 years, inclusive * Have a diagnosis of stable, moderate to severe COPD (stages II and III) as defined by guidelines of th...