A randomized, single dose, cross-over, replicated, open-label bioequivalence study comparing indacaterol/glycopyrronium (85/43mcg inhalation powder hard capsules) (PG341 [Celon Pharma] vs Ultibro Breezhaler [Novartis])
This study is looking at two types of inhalers used by adults with a lung condition called COPD (Chronic Obstructive Pulmonary Disease). One is a new version of a combination medicine (from a company called Celon Pharma), and the other is a medicine that's already on the market (Ultibro Breezhaler from Novartis). The main goal is to see if the new medicine works just as well and in the same way as the established one. This kind of research is called a 'bioequivalence study' and helps make sure that new medicines are as effective as existing ones. It's for adults, and you'd be trying both medicines to see how your body responds to each.
At a glance
What is this study about?
This study is designed to compare two similar medicines that are used by adults who have Chronic Obstructive Pulmonary Disease, often called COPD. COPD is a common lung condition that makes it difficult to breathe, and medicines like the ones in this study help to open up the airways and make breathing easier.
One of the medicines being tested is a new version of an inhaler developed by a company called Celon Pharma. The other medicine is one that many people with COPD might already be familiar with, called Ultibro Breezhaler, made by Novartis. Both medicines contain two active ingredients, indacaterol and glycopyrronium, which work together to relax the muscles around the airways in your lungs.
The main purpose of this study is to see if the new version of the medicine works in the exact same way as the already approved Ultibro Breezhaler. This is called a 'bioequivalence study.' It helps to confirm that if a new medicine is made, it will have the same effect in your body as a medicine that has already been widely used and tested. This is an important step to ensure that new medicines are safe and effective options for patients.
Key takeaways
- Compares a new COPD inhaler with an existing one.
- Checks if both medicines work the same way in the body.
- For adults aged 18 and over with COPD.
- You would try both medicines at different times.
- Aims to ensure new medicines are effective options.
Who may be eligible?
This study is for adults aged 18 or older. It is open to both men and women who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and are currently using or would benefit from regular bronchodilator treatment to help with their breathing difficulties.
To be considered for this study, you should have COPD, which is a long-term lung condition that causes breathing problems. The study focuses on adults who use medicines to help open their airways and relieve symptoms.
There might be other specific reasons why someone could not join, but these details are usually explained by the study team after a first assessment. Generally, studies like this look for participants who are otherwise in good health for their age, aside from their COPD, to ensure that the results are clear.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with COPD?
- Do you use or need regular bronchodilator medicine for your breathing?
- Are you able to attend clinic visits as required by the study?
What does participation involve?
If you decide to take part in this study, you would receive a single dose of both medicines being tested, but not at the same time. This is a 'cross-over' study, meaning you'd try one medicine, then after a set time, you'd try the other. This helps researchers compare how each medicine affects your body. You would need to attend appointments at a study clinic where medical staff would monitor you closely after you take the medicine. This involves checks like blood tests and lung function tests to see how the medicine is absorbed and how it affects your breathing. The total duration of your involvement in the study, including the different visits and follow-up, would be fully explained to you before you agree to participate.
Potential risks and benefits
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Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that makes it hard to breathe, often caused by long-term exposure to harmful gases or particles, most often from smoking.
What is an inhaler medicine for COPD?
Inhaler medicines for COPD (called bronchodilators) help relax the muscles around your airways, making them wider and easier for you to breathe. They don't cure COPD, but they help manage the symptoms.
What does 'bioequivalence' mean?
Bioequivalence means that two different versions of a medicine are expected to work in the exact same way in your body. This study wants to confirm the new medicine is 'bioequivalent' to the established one.
Will I know which medicine I'm getting?
This is an 'open-label' study, which means both you and the study team will know which medicine you are receiving at each stage of the study.
Do I have to stop my current COPD medicines?
The study team will give you specific instructions about your regular medicines. You should never stop or change your prescribed medicines without talking to your doctor or the study team first.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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