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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00500318 | A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) | PHASE3 | COMPLETED | 181 | — | — | Jul 1, 2007 | Sep 1, 2010 | Jan 6, 2017 | 52 | United States, Canada |
Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.
| Arm | Type | Description |
|---|---|---|
| Aclidinium | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Aclidinium Bromide | DRUG | Aclidinium Bromide, 200μg. Once daily oral inhalation. |
| Placebo | DRUG | Dose matched placebo, once daily oral inhalation. |
Inclusion Criteria: * A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1 \>=30% and \< 80% predicted and FEV1/FVC\<70% predicted * Current or former cigarette smoker * Functional Residual Capacity (FRC) measured by body plethysmography \>= 120% of predicted value * Ba...