NCT05733143Completed
Using Exercise-testing to Explore Patient Differences in Severe Asthma
A Cross-sectional Study Using Cardio-pulmonary Exercise Stress Testing to Understand Physiological Differences in t2-biomarker Low Severe Asthma
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
The goal of this observational pilot study is to use exercise-testing to assess patients with severe asthma who have high levels of breathlessness and compare them to other groups of patients with low levels of breathlessness. We will compare the background and overall fitness levels in all groups. This may provide new knowledge to why these patients remain breathless despite being on treatment with low levels of inflammation. The main question we aim to answer is: "How are these patients different compared to patients who respond to treatment?" We will look at reasons why patients with low levels of inflammation in their lungs are still breathless despite being on treatment. Participants will be required to take part in a 6-month study were they will firstly attend a "study visit" and a 6 month follow up. At the study visit participants will be consented and required to: * Complete questionnaires on their symptoms * Provide information on their background * Undergo a physical examination * Provide blood and urine samples for specific testing for asthma and future investigations * Perform breathing tests * Undergo an exercise-test on a treadmill During this study, researchers will compare this group will to participants who are similar but whose symptoms respond to treatment. We will also look at other groups of asthma patients who have who have different levels of inflammation in their lungs to see if there are any differences. We predict, these patients will have a different background and features to those whose symptoms respond to treatment.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 72 (actual)
- First submitted
- 31 Jan 2023
- Start date
- 18 Jul 2023
- Primary completion date
- 24 Jun 2024
- Lead sponsor
- Queen's University, Belfast
- Diseases
- Asthma
- NCT number
- NCT05733143
What you commit to
- Study type: Observational
- Participants enrolled: 72
- From 18 Jul 2023 to the primary completion date, 24 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute exacerbation requiring oral corticosteroids in previous 4 weeks before first visit
- Treatment with an investigational agent within 30 days of assessment (or five half-lives of the investigational agent, whichever is longer)
- Other clinically significant medical disease or uncontrolled concomitant disease despite treatment that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study
Other illness
- Any absolute contraindication to CPEST (Acute myocardial infarction (3-5 days), unstable angina uncontrolled arrhythmia causing symptoms or haemodynamic compromise, syncope, active endocarditis, acute myocarditis/pericarditis, symptomatic severe aortic stenosis, uncontrolled heart failure, suspected dissecting or leaking aortic aneurysm, uncontrolled asthma, arterial desaturation at rest on room air \<85%) (15)
- History of current alcohol, drug, or chemical abuse or past abuse that would impair or risk the participant's full participation in the study, in the opinion of the investigator
Other
- Female participants who are pregnant or lactating
Who the study is looking for
- All participating patients will be attending the Regional Severe Asthma Service of Belfast Trust and will be:
- Age ≥ 18 and ≤ 80 years at screening visit
- Able and willing to provide written informed consent and to comply with the study protocol
- Severe asthma confirmed after assessment by an asthma specialist as per GINA guidelines (1)
- Diagnosed with asthma at least 12 months prior to screening and on GINA Step 4/5 treatment including those who are on biologic therapy
- On optimal medical management as determined by clinician
Age in the registry: 18 years to 80 years · Sex: All
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queen's University Belfast Coordinator of this site? Confirm its status | Belfast | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.