Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Leeds

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial population

Chronic obstructive airways disease

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pulmonary function testing

    Diagnostic test

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

Treatment groups

100 Participants
are divided into 5 treatment groups
Group A: COPD1 intervention
Group B: Asthma1 intervention
Group C: Bronchiectasis1 intervention
Group D: Cystic fibrosis1 intervention
Group E: Primary ciliary dyskinesia1 intervention

Trial outcomes

Primary outcomes

1

Physical activity

Step-count

Time frame
7 day period

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Leeds

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Collaborator