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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01120093 | Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients. | PHASE2 | COMPLETED | 79 | — | — | May 1, 2010 | Aug 1, 2010 | Jan 9, 2017 | 11 | Belgium, Germany |
| Arm | Type | Description |
|---|---|---|
| Aclidinium bromide 100 μg bid | EXPERIMENTAL | Aclidininum bromide 100 μg twice daily by inhalation |
| Aclidininum bromide 200 μg bid | EXPERIMENTAL | Aclidininum bromide 200 μg twice daily by inhalation |
| Aclidininum bromide 400 μg bid | EXPERIMENTAL | Aclidininum bromide 400 μg twice daily by inhalation |
| Placebo | PLACEBO_COMPARATOR | Placebo twice-daily by inhalation |
| Formoterol 12 μg bid | ACTIVE_COMPARATOR | Formoterol 12 μg twice daily by inhalation |
| Name | Type | Description |
|---|---|---|
| Aclidinium bromide 100 μg bid | DRUG | Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days |
| Aclidinium bromide 200 μg bid | DRUG | Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days |
| Aclidininum bromide 400 μg bid | DRUG | Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days |
| Placebo | DRUG | Placebo via inhalation in the morning and evening for 7 days |
| Formoterol 12 μg bid | DRUG | Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days |
Inclusion Criteria: 1. Males and non-pregnant, non-lactating females aged ≥ 40. 2. Patients with a clinical diagnosis of stable moderate to severe COPD, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines: (http://www.goldcopd.com) and stable airway obstruction...