Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NVA237 50 µg and indacaterol 150 µg · 1 trial · 1 indication
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 %...
NVA237 50 µg and indacaterol 150 µg is an investigational combination of two small molecules being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is administered once daily and has been studied in patients with moderate to severe COPD.
NVA237 50 µg and indacaterol 150 µg is being developed by Novartis AG, a global healthcare company listed on the stock exchange under the ticker NVS. The drug is currently in Phase 3 clinical development for COPD.
NVA237 50 µg and indacaterol 150 µg is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed for this combination therapy.
NVA237 50 µg and indacaterol 150 µg was studied in a completed Phase 3 trial with the identifier NCT01604278. This randomized, double-blind, placebo-controlled trial enrolled 449 patients with moderate to severe COPD and evaluated the co-administration of NVA237 plus indacaterol versus indacaterol alone.
NVA237 50 µg and indacaterol 150 µg is a combination product that includes indacaterol 150 µg along with NVA237 50 µg. It is not the same as indacaterol alone, as it combines two active small molecule components for once-daily administration in COPD.