Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease

August 21, 2026 updated by: Dr Oliver Price, University of Leeds
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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Leeds
      • Leeds, Leeds, United Kingdom, LS2 9JT
        • University of Leeds

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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)
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)
Healthy adults
Healthy control

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Collaborators

The Leeds Teaching Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

July 31, 2026

Study Completion (Actual)

July 31, 2026

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)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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