Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NVA237 50µg once daily · 1 trial · 1 indication
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 ...
NVA237 50µg once daily is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is administered once daily at a 50 microgram dose. The drug is currently in Phase 3 clinical development and has not been approved for commercial use.
NVA237 50µg once daily is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is in Phase 3 clinical development for the treatment of Chronic Obstructive Pulmonary Disease.
NVA237 50µg once daily is in Phase 3 clinical development. It is an investigational drug being studied for the treatment of Chronic Obstructive Pulmonary Disease. The drug has not been approved by regulatory authorities and remains in clinical trials to evaluate its efficacy, tolerability, and safety.
NVA237 50µg once daily has been studied in a Phase 3 clinical trial registered as NCT01513460, titled "Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease." This randomized, double-blind, placebo-controlled trial enrolled 773 participants aged 40 years and older in Australia and New Zealand, and has been completed.
NVA237 50µg once daily is a specific dosage form of the investigational drug NVA237. The 50µg once daily designation refers to the dose and frequency of administration being studied in clinical trials for Chronic Obstructive Pulmonary Disease. The drug is being developed by Novartis AG.