RecruitingObservational

Protocol for lung sample collection by bronchoscopy for laboratory research

This study aims to collect lung and blood samples from healthy volunteers and individuals with chronic lung conditions such as COPD, asthma, and interstitial lung disease (ILD). These samples are vital for laboratory research to help scientists understand what causes these diseases and how to treat them effectively. By studying these samples, researchers hope to find new indicators of disease and improve existing treatments or develop entirely new ones. The goal is to advance our knowledge of lung diseases to benefit future patients, even though there's no direct personal benefit to participating.

At a glance

Status

Recruiting

Sponsor

Medicines Evaluation Unit

Enrolment target

3,000

Start

11 Sep 2007

Estimated completion

31 Dec 2030

Chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease (ILD)

What is this study about?

This research study is about understanding lung conditions like asthma, COPD (a common lung disease causing breathing difficulties), and interstitial lung disease (ILD, which causes scarring of the lungs). To do this, scientists need to get very detailed information directly from the lungs and blood of people who have these conditions, as well as from healthy volunteers. By comparing samples, they can learn what makes the lungs different in people with diseases and how these differences might lead to problems.

The main goal is to improve our understanding of these lung diseases, which could lead to better treatments in the future. Researchers are looking for clues, called 'markers,' that show when a disease is present or how it's progressing. They also want to see how current medicines affect the lungs and explore new ways to develop even better treatments. This kind of research is essential because it builds the foundation for future medical advancements that can help many people.

While there's no immediate health benefit for those who take part, your contribution is incredibly valuable. The information gained from your samples will help scientists unravel the mysteries of these lung diseases, potentially leading to new breakthroughs in diagnosis, treatment, and prevention for future generations. It's a way to contribute to scientific knowledge that could have a lasting impact.

Key takeaways

Aims to understand lung diseases like COPD, asthma, and ILD better.
Involves collecting lung and blood samples from healthy people and those with lung conditions.
Bronchoscopy is a key procedure, involving a small camera and sample collection from the lungs.
No direct health benefit for participants, but valuable for future research.
Participation requires at least two visits, with checks to ensure safety.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or over. You can be a healthy volunteer or have a diagnosis of COPD, asthma, or interstitial lung disease (ILD). If you have one of these lung conditions, it's important that your health has been stable, meaning no recent flare-ups or infections, for at least six weeks before you might have the procedure.

There are some specific health requirements for people with lung conditions in terms of their lung function. For example, your breathing tests will need to show your lungs are working at a certain level. Healthy volunteers should not have any long-term breathing problems or other serious health issues that could affect their lungs.

You would not be able to join if you have certain other inflammatory lung conditions, lung cancer, or if you take blood-thinning medicines like warfarin or have bleeding problems. Also, women who are pregnant or breastfeeding cannot take part for safety reasons.

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?
Do you have COPD, asthma, or ILD, or are you generally healthy without long-term breathing problems?
If you have a lung condition, has your health been stable (no recent flare-ups or infections) for at least 6 weeks?
Are you not pregnant or breastfeeding?
Are you not currently taking blood-thinning medication like warfarin?
Do you not have any other severe lung conditions or lung cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have at least two visits to the Medicines Evaluation Unit. First, you'll sign a consent form, then you'll have several tests to check if it's safe for you to have a procedure called a bronchoscopy. These tests include breathing tests (spirometry, and an additional test called DLCO for ILD patients), a physical check-up, measuring your oxygen levels with a finger clip, and blood tests for safety.

If you're suitable, the bronchoscopy will happen on a separate visit. During this procedure, a small tube (cannula) will be placed in your arm to take blood and give you a relaxing medicine. After numbing your nose and throat, a thin, flexible camera (bronchoscope) will be gently guided through your nose or mouth into your lungs. The doctor might collect tiny pieces of lung tissue (biopsy), gently brush the lung lining, or wash a small part of your lung with saline and collect it back. They might also use a small strip to soak up fluid from your lungs. Your heart rate, blood pressure, and oxygen will be watched closely.

Some people might also be asked to attend an extra visit to have samples taken from inside their nose, which could include a small tissue sample (nasal biopsy), brushing, or washing. The study overall is expected to run until December 2030, but your individual participation would involve these visits over a shorter period.

Potential risks and benefits

There are no direct personal health benefits from taking part in this study, as it's purely for laboratory research. However, your contribution is very valuable to scientific understanding, which could help others in the future. The bronchoscopy procedure will only be done if doctors believe it is safe for you. It's normal to have a slightly sore nose or throat afterwards. You might also notice a little blood in your phlegm if a biopsy or brushing was taken, which usually stops quickly. Some people might get a temporary slight fever after the procedure, which isn't serious. More serious side effects, like heavier bleeding or a small air leak from the lungs, are very rare but can occur and would be treated by the medical team. There's also a small chance of infection, and typical risks like bruising from blood tests. You can stop participating at any time if you change your mind.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Medicines Evaluation Unit Limited
City only
Manchester, England

Common questions

What is a bronchoscopy?

A bronchoscopy is a medical procedure where a thin, flexible camera is passed into your lungs through your nose or mouth to look at them and collect small samples. You will be given medicine to help you relax and to numb your nose and throat.

Will I feel pain during the bronchoscopy?

You will be given local anaesthetic to numb your nose and throat, and a relaxing medicine through a small tube in your arm, so you should not feel pain during the procedure. You might feel a sensation of pressure or discomfort, but it should not be painful.

How long will my involvement in the study last?

Your individual involvement will include at least two visits, one for checks and one for the bronchoscopy, and potentially an extra visit for nasal samples. The overall study will run for many years, but your participation is for these specific visits.

What happens to the samples collected from me?

The samples from your lungs and blood will be used for laboratory research. Scientists will study them to understand lung diseases better, identify new ways to diagnose them, and develop new treatments.

Can I leave the study if I change my mind?

Yes, taking part is completely voluntary, and you are free to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

How to find out more

Natalie Jackson

njackson@meu.org.uk +44 (0)1619464065 Official trial record

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