Characterisation of Large Airway Collapse During Exercise (LACE)

NCT04264052 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-02-17

No results posted yet for this study

Summary

The large central airways (i.e. trachea and bronchi) act as a conduit to enable lower airway ventilation but also facilitate airway clearance during dynamic manoeuvres, such as coughing. It is becoming increasingly well recognised however, that in a significant proportion of individuals with chronic airway disease (e.g. chronic obstructive pulmonary disease-COPD or chronic asthma) and in those with an elevated body mass index (BMI), that the large airways may exhibit a tendency to excessive closure or narrowing. This large airway collapse (LAC) can be associated with exertional breathlessness and difficulty clearing airway secretions. A variety of terms have been used to describe LAC including excessive dynamic airway collapse (EDAC) or if the cartilaginous structures are involved then tracheobronchomalacia (TBM).

One clear limitation of the current approach to diagnosis is the fact that many of the 'diagnostic' tests employed, utilise static, supine measures +/- forced manoeuvres. These are somewhat physiologically flawed and differ markedly from the reality of the heightened state of airflow that develops during exertion. i.e. forced manoeuvres likely induce very different turbulent and thoracic pressure changes, in contrast to the hyperpnoea of real-life physical activity (i.e. walking or cycling). A current unanswered question is therefore, what happens to the large airway dynamic movement of healthy individuals (and ultimately patients) during real-life exercise and how does this compare with the measures taken during a forced manoeuvre, either during a bronchoscopy or during an imaging study such as CT or MRI scan.

The key aim of this study is therefore to evaluate and characterise large airway movement in a cohort of healthy adults during a real-life exercise challenge and to compare this with findings from a dynamic expiratory MRI. In order to achieve this, the investigators proposes to develop and test the feasibility of an exercise-bronchoscopy protocol.

Conditions

  • Airway Disease

Interventions

DIAGNOSTIC_TEST

CBE & MRI

The diagnostic tests will be consisted by two visits. In the first visit participants will undergo a medical history assessment and they will complete questionnaires related to the lung function (MRC Dyspnoea score, Dyspnoea-12 questionnaire, and Visual Analogue Scale). A spirometry will be performed to assess the lung function. Bronchoscopy will be performed at rest in a semi-supine position (on a reclined bed) and then during exercise on a treadmill. In the second visit, spirometry and questionnaires will be performed prior to resting and during exercise measurements on a magnetic resonance imaging (MRI) scan. Rest: Structural imaging of the neck and chest will be performed followed by dynamic imaging of the airways during several inspiratory and expiratory manoeuvres. No IV contrast media will be used.

Sponsors & Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

    collaborator OTHER
  • Imperial College London

    lead OTHER

Principal Investigators

  • James Hull, Dr · Royal Brompton Hospital-Imperial College London

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2024-09-30
Completion
2024-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04264052 on ClinicalTrials.gov