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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01001494 | Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients | PHASE3 | COMPLETED | 828 | — | — | Oct 1, 2009 | Nov 1, 2010 | Jan 4, 2017 | 106 | Czechia, France +9 |
| Arm | Type | Description |
|---|---|---|
| Aclidinium bromide 200 μg bid | EXPERIMENTAL | Aclidinium bromide 200 μg twice-daily via inhalation |
| Aclidininum bromide 400 μg bid | EXPERIMENTAL | Aclidinium bromide 400 μg twice-daily via inhalation |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Aclidinium bromide 200 μg bid | DRUG | Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks |
| Aclidinium bromide 400 μg bid | DRUG | Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks |
| Placebo | DRUG | Placebo twice-daily by inhalation for 24 weeks |
Inclusion Criteria: * Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines). * Post-salbutamol (FEV1) \< 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC \< 70%. * Current or ex-smokers of ≥10 pack-years. Exclusion Criteria: * Patients wi...