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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01119950 | Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD) | PHASE2 | COMPLETED | 388 | — | — | Apr 1, 2010 | Dec 1, 2010 | Mar 23, 2015 | 29 | United States, Belgium +5 |
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. The maximal response of incremental once daily and twice daily doses of NVA237 that each dose achieves in relation to the maximal effect of NVA237 on Trough FEV1 was measured at Day 28. FEV1 was measured in response to all doses administered (see Outcome Measure #19). All trough FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All trough FEV1 data are reported as a percentage of the theoretical maximal response. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values.
| Arm | Type | Description |
|---|---|---|
| NVA237 12.5 µg q.d. | EXPERIMENTAL | NVA237 12.5 µg once daily |
| NVA237 25.0 µg q.d. | EXPERIMENTAL | NVA237 25.0 µg once daily |
| NVA237 12.5 µg b.i.d. | EXPERIMENTAL | NVA237 12.5 µg twice daily |
| NVA237 50.0 µg q.d. | EXPERIMENTAL | NVA237 50.0 µg once daily |
| NVA237 25.0 µg b.i.d. | EXPERIMENTAL | NVA237 25.0 µg twice daily |
| NVA237 100.0 µg q.d. | EXPERIMENTAL | NVA237 100.0 µg once daily |
| NVA237 50.0 µg b.i.d. | EXPERIMENTAL | NVA237 50.0 µg twice daily |
| Placebo | PLACEBO_COMPARATOR | Placebo to NVA237 once daily |
| Name | Type | Description |
|---|---|---|
| NVA237 12.5 µg once daily | DRUG | NVA237 12.5 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2. |
| NVA237 25.0 µg once daily | DRUG | NVA237 25.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2. |
| NVA237 12.5 µg twice daily | DRUG | NVA237 12.5 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2. |
| NVA237 50.0 µg once daily | DRUG | NVA237 50.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2. |
| NVA237 25.0 µg twice daily | DRUG | NVA237 25.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2. |
| NVA237 100.0 µg once daily | DRUG | NVA237 100.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2. |
| NVA237 50.0 µg twice daily | DRUG | NVA237 50.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2. |
| Placebo to NVA237 once daily | DRUG | Placebo to NVA237 via dry powder inhaler once daily for 28 days during either period 1 or during period 2. |
Inclusion Criteria: * Male and female patients age 40 years or more * Diagnosis of Chronic Obstructive Lung Disease (COPD) (moderate to severe as classified by the Global Initiative for COPD (GOLD) Guidelines, 2008 * Smoking history of at least 10 pack-years * Post-bronchodilator Forced Expiratory ...