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Also known as Glycopyrronium bromide 25ug
Glycopyrronium bromide · 3 trials · 2 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.
| 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 |
| 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 |
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...
Glycopyrronium bromide is used for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It is a small molecule respiratory therapy being developed by Novartis AG. The drug is currently in Phase 2 clinical development for asthma, while earlier Phase 3 trials for COPD have been completed.
Glycopyrronium bromide is an anticholinergic bronchodilator. It works by blocking the action of acetylcholine on muscarinic receptors in the airways, leading to relaxation of bronchial smooth muscle and improved airflow. This mechanism helps relieve symptoms in patients with respiratory conditions like COPD and asthma.
Glycopyrronium bromide is developed by Novartis AG, a multinational pharmaceutical company headquartered in Switzerland. Novartis trades on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's efficacy and safety in respiratory indications.
Glycopyrronium bromide is currently in Phase 2 clinical development for asthma. The drug has completed Phase 3 trials for chronic obstructive pulmonary disease (COPD), but it is not yet approved by the FDA. It remains an investigational agent under evaluation in clinical studies.
Glycopyrronium bromide has been studied in several clinical trials. For COPD, completed Phase 3 trials include NCT00929110 and NCT01005901. An ongoing Phase 2 trial, NCT05222529, is evaluating the drug in children aged 6 to less than 12 years with asthma. These trials assess efficacy, safety, and pharmacokinetics.
Yes, Glycopyrronium bromide 25ug is a specific dosage strength of the drug Glycopyrronium bromide. The 25 microgram formulation is being studied in clinical trials for respiratory conditions. The drug is also known by the code name NVA237 in some research contexts.