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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01604278 | Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) | PHASE3 | COMPLETED | 449 | — | — | May 1, 2012 | Jan 1, 2013 | Nov 14, 2014 | 80 | Belgium, Bulgaria +8 |
Centralized spirometry according to internationally accepted standards was used. The model contained treatment, baseline smoking status and baseline inhaled corticosteroid (ICS) use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in region as a random effect. If trough FEV1 was missing at week 12, the latest non-missing pre-dose trough FEV1 (the mean of 45 and 15 min pre-dose measurements) from day 29, 57 or 84) was carried forward. These measurements had to have been taken before the next dose of study medication. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.
| Arm | Type | Description |
|---|---|---|
| NVA237 + indacaterol | ACTIVE_COMPARATOR | - |
| Placebo to NVA237 + indacaterol | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| NVA237 50 µg and indacaterol 150 µg | DRUG | NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation. |
| Placebo to NVA237 and indacaterol 150 µg | DRUG | Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation. |
Inclusion Criteria: * Patients with moderate to severe stable Chronic Obstructive Lung Disease (COPD) Stage II or Stage III according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines. * Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 %...