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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01551888 | Pharmacokinetic, Safety and Tolerability Study of Aclidinium/Formoterol Fixed Dose Combination and Formoterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) | PHASE2 | COMPLETED | 24 | — | — | Jan 1, 2012 | Mar 1, 2012 | Feb 14, 2017 | 1 | United States |
The standard deviation of the measure is expressed as the coefficient of variation (%)
The standard deviation of the measure is expressed as the coefficient of variation (%)
The standard deviation of the measure is expressed as the coefficient of variation (%)
| Arm | Type | Description |
|---|---|---|
| Aclidinium/formoterol 400/12μg FDC | EXPERIMENTAL | Aclidinium/formoterol 400/12μg fixed-dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler |
| Formoterol | ACTIVE_COMPARATOR | Formoterol 12μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer® |
| Name | Type | Description |
|---|---|---|
| Aclidinium/formoterol 400/12μg | DRUG | Aclidinium/formoterol 400/12μg fixed dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler |
| Formoterol | DRUG | Formoterol 12 μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer® |
Inclusion Criteria: * Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years * A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway ob...