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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00510510 | Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease | PHASE2 | COMPLETED | 281 | — | — | Aug 1, 2007 | Jan 1, 2008 | May 21, 2012 | 21 | United States, France +4 |
The assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections.
| Arm | Type | Description |
|---|---|---|
| NVA237 100 µg | EXPERIMENTAL | - |
| NVA237 200 µg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| NVA237 100 µg | DRUG | Dry powder inhalation once a day for up to 28 days |
| Placebo | DRUG | Placebo to NVA237 dry powder inhalation once a day for up to 28 days |
| NVA237 200 µg | DRUG | Dry powder inhalation once a day for up to 28 days |
Inclusion Criteria: * Male or female adults aged 40 years or older * Patients with moderate to severe COPD according to the GOLD Guidelines (2006) * Patients who have smoking history of at least 10 pack years * Patients with a post-bronchodilator Forced Expiratory Volume in One Second (FEV1) equal ...