NCT05976919 Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease
| NCT ID | NCT05976919 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leeds |
| Condition | Airway Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-10-01 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 limitation, exertional dyspnoea, activity limitation and impaired quality of life. The most common conditions include chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, cystic fibrosis and primary ciliary dyskinesia. In recent years, there has been concerted effort in the scientific and respiratory medicine community to improve the diagnosis and management of chronic obstructive airways diseases using personalised or precision medicine (i.e., tailoring therapies and interventions according to specific "treatable traits") and identifying phenotypes or endotypes using validated biomarkers. To date, however, research in this setting has primarily focussed on people with COPD and asthma, with limited studies in other forms of chronic obstructive airways diseases. The aim of this study is therefore two-fold; first, to compare pulmonary physiology (i.e., large and small airway involvement) and extra-pulmonary manifestations across the spectrum of chronic obstructive airways, and second, to determine how disease-specific treatable traits associate with physical activity and health-related quality of life.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05976919 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Airway Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05976919 currently recruiting?
Yes, NCT05976919 is actively recruiting participants. Contact the research team at o.price1@leeds.ac.uk for enrollment information.
Where is the NCT05976919 trial being conducted?
This trial is being conducted at Leeds, United Kingdom.
Who is sponsoring the NCT05976919 clinical trial?
NCT05976919 is sponsored by University of Leeds. The trial plans to enroll 100 participants.