Active not recruitingOBSERVATIONAL

Using Exercise-testing to Explore Patient Differences in Severe Asthma

This study aims to understand why some people with severe asthma continue to experience extreme breathlessness, even after treatment has reduced inflammation in their lungs. We'll be comparing these individuals with severe asthma to other asthma patients who have less breathlessness or whose symptoms respond well to treatment. Participants will have a study visit and a follow-up six months later. During the visits, you'll complete questionnaires, have a physical exam, provide blood and urine samples, do breathing tests, and take a treadmill exercise test. The goal is to find out what makes these patients different, which could lead to better ways of helping people manage their severe asthma.

At a glance

Status

Active not recruiting

Sponsor

Queen's University, Belfast

Enrolment target

Start

18 Jul 2023

Estimated completion

30 Nov 2025

Asthma

What is this study about?

Imagine you have severe asthma, and even though you're taking your medicines, you still feel very breathless. Doctors have noticed that some people with severe asthma feel this way even when tests show that the inflammation in their lungs (a key part of asthma) is low. This study wants to find out why this happens.

Researchers will use special exercise tests, along with other checks, to compare people with severe asthma who are very breathless to other groups of asthma patients. This includes people whose asthma responds well to treatment, and others with different levels of inflammation. By understanding these differences, the study hopes to uncover new information about why some people struggle with breathlessness more than others.

The main idea is that if we can identify what makes these groups different, it could help doctors develop better and more personalised ways to manage severe asthma in the future. This research is about gathering knowledge to improve care for people living with this challenging condition.

Key takeaways

This study investigates why some severe asthma patients remain very breathless despite treatment.
It involves comparing patients using exercise tests and general health checks.
Participation includes two visits over six months involving various tests.
The goal is to improve understanding of severe asthma and potentially lead to better treatments.
You continue your usual asthma medications throughout the study.

Who may be eligible?

To join this study, first, you need to be a patient already attending the Regional Severe Asthma Service in Belfast Trust. You'll need to be aged between 18 and 80 years old when you first check in for the study.

It's important that your severe asthma has been confirmed by an asthma specialist, and you've had asthma for at least 12 months. You should also be on the highest level of standard asthma treatment, including biological therapies if prescribed, and your doctor must agree that your current medical management is appropriate.

There are also some reasons you wouldn't be able to join. For example, if you have certain serious heart conditions that make exercise unsafe, if you've had an asthma flare-up requiring steroid tablets in the last four weeks, or if you are pregnant or breastfeeding. The doctors will check your overall health to make sure it's safe for you to take part.

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 a patient at the Belfast Trust Regional Severe Asthma Service?
Are you aged between 18 and 80 years old?
Has an asthma specialist confirmed your severe asthma diagnosis?
Have you had asthma for at least 12 months and are on advanced treatment?
Are you able and willing to attend two study visits over six months? (including an exercise test)

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for six months. You'll need to attend two appointments: an initial 'study visit' and a '6-month follow-up visit'.

At your initial study visit, you'll first be asked to read and sign a consent form, making sure you understand everything about the study. You will then: * Fill out questionnaires about your symptoms and provide information about your background. * Have a physical examination by a doctor. * Provide blood and urine samples for asthma-related tests and future research. * Perform breathing tests to measure your lung function. * Undergo an exercise test on a treadmill to see how your body responds to activity.

Six months later, you will have a follow-up visit where some of these tests might be repeated. You will continue to take your usual asthma medications throughout the study. The researchers will compare your information with other asthma patients to understand the differences.

Potential risks and benefits

Taking part in any study has potential benefits and risks. While this study won't directly treat your asthma, the information gathered could help doctors understand severe asthma better, potentially leading to improved treatments in the future for others. Potential risks are generally low; the exercise test is performed under medical supervision, and blood/urine samples involve minor discomfort. You can also withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (1)

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

Queen's University Belfast
Verified postcode
Belfast, United Kingdom

Common questions

What is 'severe asthma' in this study?

It refers to asthma that is difficult to control, even when you're on strong medications, and still causes significant symptoms like breathlessness.

What is an 'exercise test'?

It's a test done on a treadmill where doctors monitor your heart, breathing, and other body responses while you exercise, helping them understand your fitness and breathlessness.

Will my asthma treatment change if I join?

No, you will continue to take your regular asthma medications as prescribed by your doctor throughout the study.

How long will each study visit last?

The information doesn't specify exact times, but it's likely that the initial visit, with multiple tests, will take a few hours.

Do I have to do all the tests?

To fully participate, you'd need to complete all the tests outlined, as they are crucial for the research questions. Your comfort and safety are always paramount.