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.

Study Overview

• Status: Recruiting
• Conditions: Airway Disease
• Intervention / Treatment: Diagnostic test: Pulmonary function testing

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Oliver Price, PhD; Phone Number: 01133437639; Email: o.price1@leeds.ac.uk

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9JT
    • Recruiting
    • University of Leeds
    • Contact: Oliver Price, PhD; Phone Number: 07917681623; Email: o.price1@leeds.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Chronic obstructive airways disease

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asthma	Diagnostic test: Pulmonary function testing; 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)
COPD	Diagnostic test: Pulmonary function testing; 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)
Bronchiectasis	Diagnostic test: Pulmonary function testing; 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)
Cystic fibrosis	Diagnostic test: Pulmonary function testing; 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 ciliary dyskinesia	Diagnostic test: Pulmonary function testing; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	Step-count	7 day period

Collaborators and Investigators

• Sponsor: University of Leeds
• Collaborators: The Leeds Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 323694

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No