Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease

NCT ID: NCT05976919

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-07-31

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.

Conditions

Airway Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD

Pulmonary function testing

Intervention Type: DIAGNOSTIC_TEST

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

Asthma

Pulmonary function testing

Intervention Type: DIAGNOSTIC_TEST

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

Bronchiectasis

Pulmonary function testing

Intervention Type: DIAGNOSTIC_TEST

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

Cystic fibrosis

Pulmonary function testing

Intervention Type: DIAGNOSTIC_TEST

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

Primary ciliary dyskinesia

Pulmonary function testing

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Pulmonary function testing

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Cardiopulmonary exercise testing; Physical activity (daily step count); Dual-energy X-ray absorptiometry (body composition)

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

University of Leeds

OTHER

Sponsor Role: lead

Responsible Party

Dr Oliver Price

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Leeds

Leeds, Leeds, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Oliver Price, PhD

Role: CONTACT

o.price1@leeds.ac.uk

01133437639

Facility Contacts

Oliver Price, PhD

Role: primary

o.price1@leeds.ac.uk

07917681623

Other Identifiers

323694

Identifier Type: -

Identifier Source: org_study_id