Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD
This study is looking at a new oral medicine, VPV, for people in the UK who have Chronic Obstructive Pulmonary Disease (COPD) and catch a common cold, also known as a rhinovirus infection. People with COPD can find common colds make their breathing much worse. The main goal is to see if VPV can help reduce how bad these cold symptoms get and how long they last. We're testing two different doses of VPV against a dummy medicine (placebo) to find the best and safest dose. We also want to make sure the medicine is safe to use. If you are aged 40-85, have COPD, and often interact with others, you might be suitable for this study.
At a glance
What is this study about?
For people in the UK who live with a lung condition called Chronic Obstructive Pulmonary Disease (COPD), catching a common cold can be more than just a nuisance. These colds, often caused by a virus called rhinovirus, can make your COPD symptoms much worse, leading to flare-ups (exacerbations) that can be serious. At the moment, there isn't a specific medicine to treat these cold viruses in people with COPD, so doctors often focus on managing the symptoms.
This study is testing a new medicine, called VPV, which comes as a pill you swallow. We want to see if VPV can help people with COPD when they get a common cold. Specifically, we're trying to find out if this medicine can make your cold symptoms less severe or help you recover more quickly. We're also checking to make sure the medicine is safe to use and doesn't cause too many side effects.
To do this, we're comparing two different strengths (doses) of VPV against a 'placebo', which looks exactly like the medicine but contains no active drug. This helps us understand if any improvements are truly due to the VPV medicine or if they might happen anyway. We hope this study will help us find a new way to better manage common colds for people living with COPD, potentially making a real difference to their health and quality of life.
Key takeaways
- This study is testing a new pill, VPV, for common colds in people with COPD.
- It aims to see if VPV can make cold symptoms less severe or shorter.
- We are comparing two doses of VPV against a dummy medicine (placebo).
- Participants will be aged 40-85 with a confirmed COPD diagnosis and recent flare-ups.
- Participation involves daily symptom tracking via an app and occasional nasal swabs.
- Your safety will be closely monitored throughout the study.
Who may be eligible?
To join this study, we are looking for men and women between 40 and 85 years old who have been diagnosed with COPD. You must have a confirmed diagnosis of COPD, meaning your breathing tests show specific changes, and you've had at least one COPD flare-up in the past year that needed extra treatment.
You also need to be well enough to take part and be able to follow all the study instructions. This includes being able to use a mobile app to record your symptoms daily and take samples from your nose at home. We're particularly interested in people who regularly interact with others – for example, by going to shops, eating out, or living with family members – as this means you're more likely to catch a cold during the study.
There are also some requirements about contraception if you or your partner could become pregnant. If you are sexually active, you must agree to use effective contraception throughout the study and for a period after your last dose of the study medicine. The study team will explain all of these details fully to make sure it's clear whether this study is right for 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 between 40 and 85 years old?
- Have you been diagnosed with COPD by a doctor?
- Have you had a COPD flare-up in the last year that needed extra treatment?
- Are you able to use a smartphone app daily and do nasal swabs at home?
- Do you regularly spend time interacting with other people?
- Are you willing to use effective contraception if you or your partner could become pregnant?
What does participation involve?
If you decide to join this study, your journey will involve a few key steps. First, you'll have a screening visit where doctors will check if you're suitable for the study. This will include reviewing your medical history, doing some breathing tests, and asking about your COPD flare-ups. If you are eligible, you'll be given the study medicine, which will be either VPV (at one of two different strengths) or a placebo, chosen at random like drawing lots. You won't know which one you're taking.
During the study, you'll be asked to use a special mobile app every day to record how you're feeling and your symptoms. You'll also need to do regular nasal swabs at home if you start to feel cold symptoms. There will be planned visits to the clinic, and possibly some extra visits if you catch a cold, so the study team can monitor your health and the effects of the medicine. The total time you'll be involved in the study will vary, but the main treatment and monitoring period will likely last several weeks or months. The study team will give you a full schedule if you're interested in taking part.
Potential risks and benefits
Locations (41)
- Velocity Clinical Research - MobileVerified postcodeMobile, United States· Recruiting
- AMR Clinical - TempeVerified postcodeTempe, United States· Recruiting
- 310 Clinical Research, LLCVerified postcodeInglewood, United States· Recruiting
- NewportNativeMD, Inc.Verified postcodeNewport Beach, United States· Recruiting
- Apex Clinical ResearchVerified postcodeSan Diego, United States· Recruiting
- Synergy HealthVerified postcodeBradenton, United States· Recruiting
- VM ClintrialsVerified postcodeMiami Lakes, United States· Recruiting
- Medquest Translational SciencesVerified postcodeMiami Lakes, United States· Recruiting
- Metropolitan Clinical Research CenterVerified postcodeTamarac, United States· Recruiting
- Covenant Critical Pulmonary CareVerified postcodeEast Point, United States· Recruiting
- Bioluminux Clinical Research IllinoisVerified postcodeNaperville, United States· Recruiting
- Velocity Clinical Research - ValparaisoVerified postcodeValparaiso, United States· Recruiting
Common questions
What is a rhinovirus infection?
A rhinovirus infection is simply another name for the common cold. It's a very common virus that causes symptoms like a runny nose, sneezing, and sore throat.
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease. It's a long-term lung condition that makes it difficult to breathe, often causing coughing, wheezing, and shortness of breath.
What does 'placebo' mean?
A placebo is a dummy pill or treatment that looks exactly like the real medicine but doesn't contain any active drug. We use it to compare against the new medicine to see if it truly works.
Will I know if I'm taking the real medicine or the placebo?
No, neither you nor the study doctors will know whether you are taking VPV or the placebo. This is called 'blinding' and helps ensure the study results are fair and accurate.
Can I leave the study at any time?
Yes, absolutely. Taking part is your choice, and you are free to leave the study at any point, for any reason, without affecting your medical care.
How to find out more
Karen Fusaro
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.