In short
Clinical trials investigating Glycopyrronium Bromide are studying how it fits into treatment plans for COPD and asthma. These studies look at effectiveness, safety, and patient outcomes in adults, adolescents, and children. Some trials compare Glycopyrronium Bromide in triple therapy or dual therapy against placebo or other inhaled treatments.
Key points
- Clinical trials investigating Glycopyrronium Bromide are mainly focused on COPD and asthma. Most of the studies are Phase 3, with a smaller number of Phase 2 trials in asthma, including children and adults. The trials often compare triple therapy or other inhaled combinations against dual therapy, placebo, or standard care. Common endpoints include FEV1, asthma control, exercise measures, and time to severe events. Some studies also look at health status and cardiopulmonary outcomes. The target groups vary from children with asthma to adults with COPD and older patients in specific surgery-related studies.
Clinical trials overview
The trial records show that Glycopyrronium Bromide is being studied mainly in chronic obstructive pulmonary disease and asthma. Many of the studies are interventional, which means researchers assign a treatment and then measure the results.
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. The studies are designed to look at lung function, symptom control, exercise ability, and other patient outcomes.
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. Some COPD studies also look at health status, clinical control, and severe heart or COPD events.
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. One asthma study also looks at treatment compliance, which means whether patients used the treatment as planned.
Who the studies include
The target populations vary by trial. Some studies include adults with COPD, while others include adults and adolescents with asthma. One study specifically includes children from 6 to less than 12 years old with asthma.
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. In the COPD and asthma trials, participation is usually based on disease type, age, and how well the condition is controlled.
Trial phases and study design
Most of the Glycopyrronium Bromide-related studies listed here are Phase 3 trials. Phase 3 studies usually involve larger groups of patients and compare treatments in a more advanced stage of research.
There is also a Phase 2 asthma study in children, and one study is described as low intervention. Several studies are completed, while others are authorised, meaning they have been approved to begin or continue.
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. 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.
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. Some studies also measure clinical control, health status, asthma exacerbations, compliance, and ventilation pattern complexity.
What treatments are being compared
In COPD, Glycopyrronium Bromide appears in studies comparing triple therapy with dual bronchodilator therapy or placebo. Some trials compare different inhaler formulations or propellants to see whether they give similar lung function results.
In asthma, trials compare Glycopyrronium Bromide-containing combinations with other inhaled treatments such as budesonide and formoterol, Symbicort, or placebo. 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.
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? The studies also check whether the treatment works better than current options and whether it can be used safely in the studied group.
Because the studies include different ages and disease levels, the results may apply to different patient groups in different ways. 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.