Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Glycopyrronium Bromide
NVA237 100 µg · 4 trials · 3 indications
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.
The assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections.
| Arm | Type | Description |
|---|---|---|
| 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 |
| NVA237 100 µg | EXPERIMENTAL | - |
| NVA237 200 µg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 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 |
| NVA237 100 µg | DRUG | Dry powder inhalation once a day for up to 28 days |
| NVA237 200 µg | DRUG | Dry powder inhalation once a day for up to 28 days |
Inclusion Criteria: 1\. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and: * Smoking history of at least 10 pack-years * Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value * Post-bronc...
NVA237 100 µg is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is a glycopyrronium bromide formulation studied in patients with moderate to severe COPD. The drug is not approved and remains in clinical development.
NVA237 100 µg is a small molecule containing glycopyrronium bromide, an anticholinergic agent. It is being studied for its safety and tolerability in patients with moderate to severe COPD. The specific molecular target is not disclosed in the available information.
NVA237 100 µg is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is currently in Phase 2 clinical development for the treatment of Chronic Obstructive Pulmonary Disease (COPD).
NVA237 100 µg is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD) in patients with moderate to severe disease.
NVA237 100 µg has one completed clinical trial, registered as NCT00510510. This Phase 2 study evaluated the safety and tolerability of 28 days of treatment with glycopyrronium bromide (NVA237) at 100 or 200 µg once daily in 281 patients with moderate to severe COPD. The trial was randomized, double-blind, and placebo-controlled.
NVA237 100 µg is a formulation of glycopyrronium bromide, an anticholinergic bronchodilator. The drug is being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD). The 100 µg dose refers to the amount of glycopyrronium bromide administered once daily in the clinical trial.