Active not recruitingPHASE4INTERVENTIONAL

A Bronchoscopy Study to Assess the Effects of Inhaled Corticosteroids on Adult Healthy Volunteers

Researchers are conducting a study to understand how a common inhaled steroid medicine, called fluticasone propionate, affects the cells and genes in the lungs of healthy adults. This medicine is often used in asthma treatment. By studying healthy volunteers, scientists can tell the difference between changes caused by the medicine and changes caused by asthma itself. This knowledge is very important for finding new and better ways to treat severe asthma in the future. Participants will be healthy adults aged 18-65. Some will use the inhaled medicine for four weeks, while others will not receive any treatment. Lung samples will be taken before and after this period to see the effects. The study aims to improve our understanding of lung health and serious lung conditions.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

University Hospitals, Leicester

Enrolment target

Start

20 Jan 2016

Estimated completion

31 Oct 2026

Healthy

What is this study about?

This study wants to learn more about how a common medicine called fluticasone propionate affects the airways inside our lungs. Fluticasone propionate is an inhaled steroid often used to treat conditions like asthma. What we want to find out is how this medicine changes the way cells in the airways behave and what genes they use, specifically in healthy people who don't have asthma. Understanding this in healthy individuals helps us separate the effects of the medicine from the effects of the disease itself.

Why is this important? By knowing what the medicine does in healthy lungs, we can better understand what's happening in people with severe asthma. This deeper understanding could lead to new discoveries and help create more effective treatments for those who don't respond well to current asthma medications. Basically, it's about getting to the root of how these medicines work so we can improve future care.

About 30 healthy adult volunteers will take part. Some will use the inhaled medicine for four weeks, and others will not. Before and after this period, doctors will perform a procedure called a bronchoscopy to collect tiny samples from the airways. This allows them to examine the cells and genes closely. This information is key to developing better medicines for lung conditions like severe asthma.

Key takeaways

This study helps scientists understand how asthma medicines affect healthy lungs.
It aims to find new ways to treat severe asthma.
Healthy adults (18-65) are needed as volunteers.
Participation involves either taking an inhaled medicine or no treatment for four weeks.
You'll have a bronchoscopy procedure at the beginning and end of the study.
Your contribution is vital for medical progress but offers no direct personal health benefits.

Who may be eligible?

To join this study, you need to be a healthy adult between 18 and 65 years old. Your lungs need to be working well, which doctors will check with breathing tests. If you smoke, you must have quit over a year ago and haven't smoked much in your lifetime.

Women who could become pregnant must be using effective birth control during the study. You'll also need to have good results from general health checks like blood tests and an ECG (heart test). A chest X-ray will be done to make sure your lungs are clear of any major problems. We'll also check for allergies and asthma, and you must not have asthma or severe allergies.

You cannot take part if you are pregnant, breastfeeding, or planning to become pregnant. If you've had a severe allergic reaction to steroids before, or have taken steroid medicine recently, you wouldn't be able to join. We also can't include people who have had certain severe infections or other serious health problems recently, including certain liver conditions or active tuberculosis. It’s important that you're well enough to participate and can follow all the study instructions.

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 18 and 65 years old?
Do you have healthy lungs (no asthma or other significant lung diseases)?
Have you been a non-smoker for over a year?
Are you generally healthy with no severe allergies or recent serious infections?
If you're a woman, are you using effective contraception and not pregnant or breastfeeding?
Are you willing and able to attend all study appointments and procedures?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit. During this visit, we'll explain the study in detail, answer your questions, and ask for your written permission (informed consent). We'll also do several health checks, like blood tests, an ECG, breathing tests, and a chest X-ray, to make sure you're suitable for the study. You'll then be randomly placed into one of two groups: either you'll use the inhaled medicine (fluticasone propionate) with an Accuhaler twice a day for four weeks, or you'll be in a group that doesn't receive any treatment for those four weeks.

At the beginning of the study, and again after four weeks, you will have a bronchoscopy procedure. This involves a thin, flexible tube with a camera being gently passed into your airways, usually after you've been given some medicine to make you comfortable. Tiny samples will be taken from your airways during this procedure. The total study duration will be about four weeks of treatment or no treatment, plus the time for clinic visits and follow-up. If you need to stop participating for any reason, you are free to do so at any time.

Potential risks and benefits

A potential benefit of joining this study is contributing to important medical research that could lead to better treatments for severe asthma in the future. While there are no direct health benefits for you, your participation helps scientists gain vital knowledge. Potential risks include those associated with the bronchoscopy procedure, such as discomfort, sore throat, or a small risk of bleeding or infection, though these are typically rare. The inhaled medicine used is generally safe, but like all medicines, it can have side effects, which will be fully explained to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

University Hospitals of Leicester NHS Trust
Verified postcode
Leicester, United Kingdom

Common questions

What is a 'bronchoscopy'?

It's a procedure where a thin, flexible tube with a tiny camera is gently put into your airways to look inside and take small samples. You'll be given medicine to make you comfortable.

What is fluticasone propionate?

It's an inhaled steroid medicine commonly used to reduce inflammation in the airways, often prescribed for conditions like asthma.

Will I definitely receive the medicine?

You will be randomly assigned to either receive the medicine for four weeks or to receive no treatment for four weeks. It's like flipping a coin for which group you're in.

Will I know if I'm getting the medicine or not?

No, you won't know which group you're in (single-blind). This is to make sure your expectations don't affect the study results.

How long will I be involved in the study?

The main part of the study involves four weeks of either using the medicine or having no treatment, plus a few clinic visits and procedures before and after that period.