Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease

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.

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Key information

Conditions

Airway Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Leeds

Leeds, LS2 9JT, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Pulmonary Function Testing

Diagnostic Test

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

Other names: Cardiopulmonary exercise testing, Physical activity (daily step count), Dual-energy X-ray absorptiometry (body composition)

Primary outcomes

Physical activity

Time frame: 7 day period

Step-count

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Collaborators

The Leeds Teaching Hospitals NHS Trust

Registry information

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Aug 4, 2023
Registry last updated: Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed