Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease

NCT05976919 | Recruiting

• 1 other identifier: 323694
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Physical activity

  Step-count

  7 day period

Study Arms (5)

COPD

Diagnostic Test: Pulmonary function testing

Asthma

Diagnostic Test: Pulmonary function testing

Bronchiectasis

Diagnostic Test: Pulmonary function testing

Cystic fibrosis

Diagnostic Test: Pulmonary function testing

Primary ciliary dyskinesia

Diagnostic Test: Pulmonary function testing

Interventions

Pulmonary function testing DIAGNOSTIC_TEST

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

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

Asthma; Bronchiectasis; COPD; Cystic fibrosis; Primary ciliary dyskinesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic obstructive airways disease

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Leeds: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator

Study Sites (1)

University of Leeds

Leeds, Leeds, LS2 9JT, United Kingdom

RECRUITING

MeSH Terms

Interventions

Respiratory Function Tests; Exercise Test; Exercise; Absorptiometry, Photon; Body Composition

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Ergometry; Investigative Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical; Biochemical Phenomena; Chemical Phenomena; Metabolism; Body Constitution; Physiological Phenomena

Central Study Contacts

Oliver Price, PhD

CONTACT

01133437639; o.price1@leeds.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: October 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)