Table of contents
- Clinical trials overview
- Conditions studied
- Who the studies include
- Trial phases and study design
- Main endpoints measured
- What treatments are being compared
- What these studies mean for patients
Clinical trials overview
The trial records show that Glycopyrronium Bromide is being studied mainly in chronic obstructive pulmonary disease and asthma.[1][2] Many of the studies are interventional, which means researchers assign a treatment and then measure the results.[1]
Several trials test Glycopyrronium Bromide as part of a triple therapy or combined inhaled treatment, while others compare it with dual therapy, placebo, or another active treatment.[1][2] The studies are designed to look at lung function, symptom control, exercise ability, and other patient outcomes.[1][2]
Conditions studied
The largest group of trials focus on COPD, including stable COPD, moderate to severe COPD, and COPD with hyperinflation, which means extra air trapped in the lungs.[1][2] Some COPD studies also look at health status, clinical control, and severe heart or COPD events.[1][2]
Asthma studies include severe and inadequately controlled asthma, uncontrolled asthma, mild to moderate asthma, and asthma in children aged 6 to less than 12 years.[2][3] One asthma study also looks at treatment compliance, which means whether patients used the treatment as planned.[2]
Who the studies include
The target populations vary by trial. Some studies include adults with COPD, while others include adults and adolescents with asthma.[1][2] One study specifically includes children from 6 to less than 12 years old with asthma.[3]
Some trials also focus on special groups, such as high-risk GOLD B patients with COPD, symptomatic ICS-naive COPD patients with asthma-like features, and elderly patients in anesthesia-related research.[1][2] In the COPD and asthma trials, participation is usually based on disease type, age, and how well the condition is controlled.[2][3]
Trial phases and study design
Most of the Glycopyrronium Bromide-related studies listed here are Phase 3 trials.[1][2] Phase 3 studies usually involve larger groups of patients and compare treatments in a more advanced stage of research.[1]
There is also a Phase 2 asthma study in children, and one study is described as low intervention.[3][1] Several studies are completed, while others are authorised, meaning they have been approved to begin or continue.[1][2]
Main endpoints measured
The most common endpoint is FEV1, or forced expiratory volume in 1 second, which measures how much air a person can blow out in one second.[1][3] Trials measure FEV1 in different ways, such as pre-dose morning FEV1, trough FEV1, or change from baseline, which means the difference from the starting value.[1][3]
Other endpoints include isotime inspiratory capacity, which looks at how much air a person can breathe in during exercise at the same time point, and time to first severe cardiac or COPD event.[4][5] Some studies also measure clinical control, health status, asthma exacerbations, compliance, and ventilation pattern complexity.[2][6]
What treatments are being compared
In COPD, Glycopyrronium Bromide appears in studies comparing triple therapy with dual bronchodilator therapy or placebo.[1][4] Some trials compare different inhaler formulations or propellants to see whether they give similar lung function results.[7]
In asthma, trials compare Glycopyrronium Bromide-containing combinations with other inhaled treatments such as budesonide and formoterol, Symbicort, or placebo.[3][8] One study also compares treatment delivery methods, such as monthly nurse-administered treatment versus self-administered treatment with an auto-injector pen, but that study is about mepolizumab and not Glycopyrronium Bromide itself.[6]
What these studies mean for patients
For patients, these trials are trying to answer practical questions: does the treatment improve breathing, reduce flare-ups, or help people feel more controlled?[1][2] The studies also check whether the treatment works better than current options and whether it can be used safely in the studied group.[1][3]
Because the studies include different ages and disease levels, the results may apply to different patient groups in different ways.[2][3] The trial data show a strong focus on measuring lung function and patient control, which are important signs of how well treatment is helping in real life.[1][4]
