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Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease

Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05976919
Enrollment
100
Registered
2023-08-04
Start date
2023-10-01
Completion date
2025-07-31
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Disease

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.

Interventions

Physiological assessment of pulmonary physiology (large and small airways), exercise capacity, physical activity and body composition.

Sponsors

The Leeds Teaching Hospitals NHS Trust
CollaboratorOTHER
University of Leeds
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Physical activity7 day periodStep-count

Countries

United Kingdom

Contacts

Primary ContactOliver Price, PhD
o.price1@leeds.ac.uk01133437639

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026