Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Glycopyrronium Bromide
NVA237 50 µg and indacaterol 150 µg · 4 trials · 3 indications
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.
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included baseline FEV1 measurement, baseline inhaled corticosteroid use (Yes/No), FEV1 prior to inhalation of short-acting β2 agonist (SABA), and FEV1 45 min post-inhalation of SABA as covariates.
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry.
| Arm | Type | Description |
|---|---|---|
| NVA237 + indacaterol | ACTIVE_COMPARATOR | - |
| Placebo to NVA237 + indacaterol | PLACEBO_COMPARATOR | - |
| Glycopyrronium bromide | EXPERIMENTAL | Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication. |
| Placebo | PLACEBO_COMPARATOR | Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication. |
| Glycopyrronium bromide 50 μg | EXPERIMENTAL | Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| Placebo to glycopyrronium bromide | PLACEBO_COMPARATOR | Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| Tiotropium 18 μg | ACTIVE_COMPARATOR | Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| Glycopyrronium 25μg | EXPERIMENTAL | Glycopyrronium 25μg for two weeks |
| Glycopyrronium 12.5μg | EXPERIMENTAL | Glycopyrronium 12.5μg for two weeks |
| 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. |
| Glycopyrronium bromide | DRUG | Glycopyrronium bromide 50µg was supplied as inhalation capsules for use via a Single Dose Dry Powder Inhaler (SDDPI) |
| Placebo | DRUG | Placebo inhalation capsules were provided for use via a SDDPI |
| Placebo to glycopyrronium bromide | DRUG | Placebo to glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. |
| Tiotropium | DRUG | Tiotropium was supplied in powder-filled capsules together with the Handihaler® device. |
| Glycopyrronium bromide 25ug | DRUG | 25μg Glycopyrronium bromide capsules for oral inhalation via Breezhaler |
| Glycopyrronium bromide 12.5ug | DRUG | 12.5ug Glycopyrronium bromide capsules for oral inhalation via Breezhaler |
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.