C4531031 - AN INTERVENTIONAL PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY-UNBLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
This research study is looking for adults aged 18 and over who have moderate to severe Chronic Obstructive Pulmonary Disease (COPD). We are testing a new potential medicine, PF-07275315, to see if it can help improve lung function and reduce the number of sudden worsening of symptoms, also known as flare-ups or exacerbations. Some participants will receive the new medicine, while others will receive a dummy medicine (placebo), so we can compare the effects. The study aims to understand how well the medicine works and if it's safe to use for people with COPD.
At a glance
What is this study about?
You might be reading this because you, or someone you know, lives with Chronic Obstructive Pulmonary Disease (COPD). It's a condition that makes it hard to breathe because of narrowed airways. This study is testing a new potential medicine called PF-07275315, which we hope might help people with moderate to severe COPD.
This study has two main parts, called Phase 2 and Phase 3. In Phase 2, we want to get an early idea of how well the new medicine works and if it's safe. We'll be looking closely at how much it improves your breathing, measured by something called FEV1, which is how much air you can forcefully breathe out in one second. We'll compare this to a dummy medicine (a placebo) to see if the new medicine makes a difference.
In Phase 3, if the medicine shows promise in Phase 2, the study will expand to gather more information. Here, the main goal will be to see if the new medicine can reduce the number of times people have moderate or severe COPD flare-ups over a year. Flare-ups can be very serious and lead to hospital visits, so finding a medicine that helps reduce them would be a big step forward. We'll also look at how the medicine affects your quality of life and daily symptoms.
Key takeaways
- This study is for adults with moderate to severe COPD.
- It tests a new medicine (PF-07275315) against a dummy medicine (placebo).
- Aims to improve breathing and reduce COPD flare-ups.
- Participation involves regular clinic visits and health checks.
- You won't know if you're getting the active medicine or placebo.
- You can leave the study at any time.
Who may be eligible?
This study is looking for adults who are 18 years old or older. Both men and women can take part.
You would need to have been diagnosed with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). This means your doctor has confirmed your COPD and it's not a mild case.
There might be other health conditions or medicines that would mean you can't join the study, to make sure it's safe for everyone. The study team will discuss all the requirements with you.
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 moderate to severe COPD by a doctor?
- Are you willing to attend regular clinic appointments?
- Are you comfortable with the possibility of receiving a dummy medicine?
- Do you understand that there might be unknown side effects?
What does participation involve?
If you decide to take part, you'll be randomly put into one of two groups. One group will receive the new investigational medicine, PF-07275315, and the other group will receive a placebo, which looks just like the real medicine but contains no active ingredients. Neither you nor your study doctor will know which you are receiving, to keep the results fair. Another unblinded team will know for safety reasons.
You'll have several visits to the study clinic over the course of the study. These visits will involve various assessments, such as breathing tests to measure your lung function (like FEV1 and FVC), heart checks (ECG), blood tests, and physical examinations. You'll also be asked questions about your symptoms and how you're feeling, possibly using questionnaires like the Saint George's Respiratory Questionnaire (SGRQ) or the COPD Assessment Test (CAT).
The total length of the study, including follow-up, will be determined by the specific phase you participate in, but it could last over a year.
Potential risks and benefits
Locations (4)
- —UnverifiedGermany
- —UnverifiedCzechia
- —UnverifiedGreece
- —UnverifiedItaly
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease, a common lung condition that causes narrowed airways and breathing difficulties.
What does 'randomized' mean?
It means you'll be put into a treatment group (either the new medicine or dummy medicine) by chance, like flipping a coin, to ensure fairness.
What is a 'placebo'?
A placebo is a dummy medicine that looks like the real thing but contains no active drug. It helps us see if the new medicine has a true effect.
Will I know if I'm getting the new medicine?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know if you're receiving the new medicine or the placebo.
What is a 'flare-up' or 'exacerbation'?
This is when COPD symptoms suddenly get worse, sometimes leading to hospital visits. The study wants to see if the new medicine reduces these.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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