Status:
RECRUITING
Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease
Lead Sponsor:
University of Leeds
Collaborating Sponsors:
The Leeds Teaching Hospitals NHS Trust
Conditions:
Airway Disease
Eligibility:
All Genders
18-65 years
Brief Summary
Respiratory disease affects one in five people and is a leading cause of global morbidity and mortality. Chronic obstructive airways diseases encompass conditions characterised by expiratory airflow l...
Eligibility Criteria
Inclusion
- Prior diagnosis of airways disease in accordance with European Respiratory Society guidelines.
- Non / ex-smokers (packs recorded as cigarettes per day / years smoked).
- Male or female aged 18-65 years
- Ability to provide written informed consent.
- Full comprehension of spoken and written English language.
- Cystic Fibrosis patients on triple CFTR modulators (90% cohort)
- Cystic Fibrosis patients on no CFTR modulators
- Healthy controls - entirely asymptomatic, no prior history of inhaler medication use and free from respiratory disease.
Exclusion
- Severe exacerbation requiring hospital admission or oral corticosteroids (OCS) in the past two months.
- Absolute or relative contraindications to cardio-pulmonary exercise testing or submaximal exercise testing.
- Absolute or relative contraindications to pulmonary function testing .
- Absolute or relative contraindications to dual energy x-ray (DEXA) scanning (i.e., pregnancy, recent contrast media administration or subject weight).
- Non-ambulant or musculoskeletal impairment that may affect activities of daily living or maximal exercise testing.
- Significant cognitive impairment (i.e., unable to provide written informed consent or safely / successfully perform tests).
- Currently receiving oxygen therapy.
- Inability to consent.
- Burkholderia Cepacia Complex, mycobacterium tuberculosis or mycobacterium abseccus infection.
- Lung transplantation
- Diagnosis of cardiovascular disease.
- Abnormal blood screening (anaemia, moderate / severe renal failure etc.)
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05976919
Start Date
October 1 2023
End Date
July 31 2025
Last Update
March 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Leeds
Leeds, Leeds, United Kingdom, LS2 9JT