Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease

Last updated: March 25, 2025
Sponsor: University of Leeds
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Pulmonary function testing

Clinical Study ID

NCT05976919
323694
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Prior diagnosis of airways disease in accordance with European Respiratory Societyguidelines.

  • 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 useand free from respiratory disease.

Exclusion

Exclusion Criteria:

  • Severe exacerbation requiring hospital admission or oral corticosteroids (OCS) inthe past two months.

  • Absolute or relative contraindications to cardio-pulmonary exercise testing orsubmaximal 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 dailyliving or maximal exercise testing.

  • Significant cognitive impairment (i.e., unable to provide written informed consentor safely / successfully perform tests).

  • Currently receiving oxygen therapy.

  • Inability to consent.

  • Burkholderia Cepacia Complex, mycobacterium tuberculosis or mycobacterium abseccusinfection.

  • Lung transplantation

  • Diagnosis of cardiovascular disease.

  • Abnormal blood screening (anaemia, moderate / severe renal failure etc.)

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Pulmonary function testing
Phase:
Study Start date:
October 01, 2023
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • University of Leeds

    Leeds, LS2 9JT
    United Kingdom

    Active - Recruiting

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