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Glycopyrronium/Formoterol · 1 trial · 1 indication
To assess the effects of GFF relative to UV on lung function as measured by change from baseline in morning pre-dose trough FEV1 is defined as the average of the -60 and -30 minute pre-dose values at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1). BR a/s = bronchodilator responsiveness to albuterol/salbutamol.
To assess the effects of GFF relative to UV on lung function in PP analysis set population as measured by peak change from baseline in FEV1 is defined as the maximum of the FEV1 assessments within the 2 hours post-dosing time windows at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1).
To assess the effects of GFF relative to UV on lung function in FAS population as measured by peak change from baseline in FEV1 is defined as the maximum of the FEV1 assessments within the 2 hours post-dosing time windows at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1).
| Arm | Type | Description |
|---|---|---|
| Experimental | EXPERIMENTAL | glycopyrronium/formoterol fumarate 7.2/4.8 μg per actuation, twice daily |
| Active comparator | ACTIVE_COMPARATOR | umeclidinium/vilanterol 62.5/ 25μg per inhalation, once daily |
| Name | Type | Description |
|---|---|---|
| Glycopyrronium/Formoterol Fumarate | DRUG | Metered dose inhaler (MDI), contains glycopyrronium/formoterol fumarate fixed-dose combination 7.2/4.8 μg per actuation |
| umeclidinium/vilanterol | DRUG | Dry powder inhaler (DPI), Each metered dose contains umeclidinium/vilanterol 62.5/ 25μg fixed-dose combination per inhalation |
Inclusion criteria: * Age 40-95 years at screening * Current or former smoker with a history of at least 10 pack-years of cigarette smoking * Current clinical diagnosis of COPD, with COPD symptoms \> 1 year prior to screening, as defined by GOLD criteria or other current guidelines * COPD Severity ...
Glycopyrronium/Formoterol is an investigational fixed-dose combination of two small molecules being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is intended for patients with moderate to very severe COPD. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Glycopyrronium/Formoterol combines a long-acting muscarinic antagonist (glycopyrronium) and a long-acting beta-agonist (formoterol). These two bronchodilators work through different mechanisms to relax airway muscles and improve lung function in patients with COPD. The combination is designed to provide complementary effects for symptom control.
Glycopyrronium/Formoterol is being developed by AstraZeneca PLC, a global biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the efficacy and safety of this fixed-dose combination for the treatment of Chronic Obstructive Pulmonary Disease.
Glycopyrronium/Formoterol is in Phase 3 clinical development. A Phase 3 trial has been completed, comparing the fixed-dose combination to an active control in patients with moderate to very severe COPD. The drug remains investigational and is not yet approved for commercial use.
Glycopyrronium/Formoterol has one completed Phase 3 clinical trial registered as NCT03162055. This 24-week study evaluated the efficacy and safety of the fixed-dose combination compared to umeclidinium/vilanterol in 1,119 patients with moderate to very severe COPD. The trial was conducted in the United States, Bulgaria, Canada, France, Hungary, Russia, and Ukraine.
No, Glycopyrronium/Formoterol is not the same as umeclidinium/vilanterol. These are two different fixed-dose combinations of bronchodilators. Glycopyrronium/Formoterol combines glycopyrronium and formoterol, while umeclidinium/vilanterol combines umeclidinium and vilanterol. In a clinical trial, Glycopyrronium/Formoterol was directly compared to umeclidinium/vilanterol as an active control.