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RecruitingNAINTERVENTIONAL

A Rhinovirus Challenge Study to Investigate Exacerbations and Immune Responses in Bronchiectasis

This study aims to understand why common cold viruses, like rhinovirus, often cause flare-ups (exacerbations) in people with a lung condition called bronchiectasis. We want to see if catching a cold leads to a flare-up and if the body's response to the virus is different in people with bronchiectasis compared to healthy individuals. To do this, participants will have a small amount of common cold virus sprayed into their nose. Researchers will then closely monitor their health and immune responses over several weeks. The goal is to gain important knowledge that could help us find better ways to prevent and treat these flare-ups in the future.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Imperial College London
Enrolment target
54
Start
24 Jul 2024
Estimated completion
30 Oct 2027

What is this study about?

Bronchiectasis is a long-term lung condition that affects many people in the UK. We know that viruses, especially those that cause the common cold (like rhinovirus), often trigger flare-ups, also known as exacerbations, in people with bronchiectasis. These flare-ups can make symptoms worse and lead to hospital stays. However, we don't fully understand why these viruses cause problems in people with bronchiectasis or why their immune systems might react differently.

This study is designed to help us answer these important questions. By doing so, we hope to learn more about how viruses lead to flare-ups in bronchiectasis. This knowledge is crucial for developing better ways to predict, prevent, or treat these flare-ups, ultimately improving the lives of people living with this condition.

To achieve this, we will gently give participants a common cold virus and then carefully observe their health. We'll be looking at things like their symptoms, their lung function, and how their immune system responds. We will compare people with bronchiectasis to healthy volunteers to see where the differences lie.

Key takeaways

  • Researchers are studying how common cold viruses affect people with bronchiectasis.
  • The study aims to understand why flare-ups occur and how the immune system responds.
  • Participants will be given a common cold virus and closely monitored for 6 weeks.
  • The results could help develop better ways to prevent and treat bronchiectasis flare-ups.
  • The study is for adults aged 18-65, including both healthy volunteers and those with bronchiectasis.

Who may be eligible?

To join this study, you need to be between 18 and 65 years old. If you have bronchiectasis, it needs to be a confirmed diagnosis, and your condition should not be too severe. We are also looking for healthy volunteers of the same age group.

There are certain reasons why you might not be able to take part. For example, if you've smoked recently (in the last year) or if you have certain other serious health conditions. We also can't include people who are pregnant or breastfeeding, or those who have regular close contact with babies or elderly individuals.

If you have bronchiectasis, you wouldn't be able to join if your condition is due to certain other specific diseases, or if your lung function is very low. Also, if you've recently taken antibiotics or certain steroid medications, you might need to wait before joining the study.

Quick self-check
  • Are you between 18 and 65 years old?
  • Do you have a confirmed diagnosis of bronchiectasis, or are you a healthy adult?
  • Have you not smoked in the last 12 months?
  • Are you not pregnant or breastfeeding?
  • Have you not used antibiotics or certain steroid medications in the last 4-6 weeks (if you have bronchiectasis)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check if you're suitable. This will involve some lung function tests, checking your height and weight, answering questions about your medical history, and a blood test. Women will also have a pregnancy test.

If you're eligible, you'll then come for a baseline visit. During this visit, you'll have more blood tests, a physical check-up, and you might have some small samples taken from your nose. You will then have a small amount of common cold virus (Rhinovirus A-16) sprayed into your nose.

After receiving the virus, you'll be monitored closely for about 6 weeks. This will involve regular visits where you might have lung function tests, more blood samples, samples from your nose (like gently wiping inside or flushing with a saline solution), and collecting any sputum you cough up. For some participants, a lung procedure called a bronchoscopy might be done. You'll also be asked to keep a daily diary of your symptoms throughout the study. The study takes place in London at St Mary's Hospital.

Potential risks and benefits

Taking part in a study like this helps us learn more about bronchiectasis, which could lead to better treatments for everyone in the future. You will be closely monitored by a medical team, but there are potential risks, such as experiencing common cold symptoms due to the virus, or discomfort from procedures like blood tests or nasal samples. If you have bronchiectasis, there is a risk of having a flare-up. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • St Mary's Hospital - Imperial Clinical Respiratory Research Unit (ICRRU)
    London, United Kingdom· Recruiting

Common questions

What is bronchiectasis?

Bronchiectasis is a long-term lung condition where the airways become widened and scarred, making them more prone to infection and inflammation.

What is a 'flare-up'?

A 'flare-up' or 'exacerbation' is when your bronchiectasis symptoms, like coughing or shortness of breath, suddenly get worse.

Will I get very sick from the common cold virus?

You will be given a common cold virus and will likely develop cold symptoms, but you will be closely monitored by doctors and nurses throughout the study for your safety.

Where does the study take place?

The study takes place at one location: ICRRU within Imperial College Healthcare NHS site at St Mary's Hospital in London.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, and it will not affect your usual medical care.

How to find out more

Charlotte E Carter, MBChB

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Rhinovirus Challenge Study to Investigate Exacerbations an…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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