Exploring patient differences in severe asthma through exercise testing
A Cross-sectional Study Using Cardio-pulmonary Exercise Stress Testing to Understand Physiological Differences in t2-biomarker Low Severe Asthma
Queen's University, Belfast · NCT05733143
This study is trying to see how exercise affects people with severe asthma who feel very breathless compared to those who don’t, to better understand their different experiences.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Queen's University, Belfast (other) |
| Drugs / interventions | mepolizumab, benralizumab, reslizumab, dupilumab, Tezepelumab |
| Locations | 1 site (Belfast, Northern Ireland) |
| Trial ID | NCT05733143 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to assess patients with severe asthma who experience high levels of breathlessness and compare them to those with low levels of breathlessness. Participants will undergo cardiopulmonary exercise stress testing (CPEST) and complete questionnaires regarding their symptoms and background. The study seeks to understand why some patients remain breathless despite low levels of inflammation and optimal treatment. Over a 6-month period, participants will attend a study visit and a follow-up to gather comprehensive data on their condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with severe asthma who are on maximal treatment as per GINA guidelines.
Not a fit: Patients with absolute contraindications to cardiopulmonary exercise stress testing or those with uncontrolled asthma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of severe asthma, potentially enhancing treatment strategies for patients who do not respond adequately to current therapies.
How similar studies have performed: While there have been studies on asthma management, this specific approach using exercise testing to differentiate patient responses is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria All participating patients will be attending the Regional Severe Asthma Service of Belfast Trust and will be: 1. Age ≥ 18 and ≤ 80 years at screening visit 2. Able and willing to provide written informed consent and to comply with the study protocol 3. Severe asthma confirmed after assessment by an asthma specialist as per GINA guidelines (1) 4. Diagnosed with asthma at least 12 months prior to screening and on GINA Step 4/5 treatment including those who are on biologic therapy 5. On optimal medical management as determined by clinician Exclusion criteria Exclusion criteria will be: 1. 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) 2. Acute exacerbation requiring oral corticosteroids in previous 4 weeks before first visit 3. 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 4. Treatment with an investigational agent within 30 days of assessment (or five half-lives of the investigational agent, whichever is longer) 5. Female participants who are pregnant or lactating 6. 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
Where this trial is running
Belfast, Northern Ireland
- Queen's University Belfast — Belfast, Northern Ireland, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Liam G Heaney, MD — Queens University Belfast
- Study coordinator: Liam G Heaney, MD
- Email: l.heaney@qub.ac.uk
- Phone: 0044 28 9097 6376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Asthma, asthma, Cardiopulmonary exercise stress testing