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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01513460 | Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease | PHASE3 | COMPLETED | 773 | — | — | Apr 1, 2012 | Dec 1, 2013 | Jan 5, 2015 | 71 | Australia, New Zealand |
Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15 hours and 23:45 hours after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45 min and 15 min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| NVA237 + Fluticasone/Salmeterol (Flu/Sal) | EXPERIMENTAL | NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication. |
| Tiotropium + Flu/Sal | ACTIVE_COMPARATOR | Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication. |
| Flu/Sal | PLACEBO_COMPARATOR | Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication. |
| Name | Type | Description |
|---|---|---|
| NVA237 50µg once daily | DRUG | NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) |
| Tiotropium 18µg once daily | DRUG | Tiotropium 18 μg o.d. delivered via a proprietary inhalation device |
| Flu/Sal | DRUG | Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device |
| NVA237 placebo + Tiotropium placebo. | DRUG | Tiotropium 18 μg o.d. delivered via a proprietary inhalation device |
Inclusion Criteria: * Patients with Moderate to Severe COPD (Stage II or Stage III) according to the GOLD 2010 guideline * Current or ex-smokers who have a smoking history of at least 10 pack years * Qualifying FEV1 at Visit 2 (day -7) Exclusion Criteria: * Patients with a history of asthma or a ...