Characterisation of Large Airway Collapse During Exercise (LACE)

NCT04264052 | Unknown

• 1 other identifier: 19IC5362
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

excessive dynamic airway collapse; tracheobronchomalacia; large airways collapse

Outcome Measures

Primary Outcomes (1)

• Feasibility of continuous bronchoscopy during exercise (CBE): questionnaire

  Primary outcome will be the feasibility of continuous bronchoscopy during continuous exercise in healthy adults. Feasibility will be assessed via a post CBE tolerability questionnaire. The post exercise tolerability questionnaire aims to evaluate the upper airways function during exercise and the discomfort that the participant might experience during the test. It consists of 5 questions (Part A) where the score ranges from 1 (strongly disagree) to 5 (strongly agree), and 2 questions (Part B) where the score ranges from 1 (None at all) to 10 (Unbearable amount). The total score that will confirm the feasibility of CBE should be \< 3 or \< 5, for Part A and B, respectively. The questions relate to the tolerability of the CBE test (e.g., Exercise with the camera in place cause discomfort, 1 (strongly agree) to 5 (strongly disagree).

  12 months

Secondary Outcomes (3)

• Diagnostic capacity of CBE and MRIE

  12 months

• Comparing dynamic versus physical exertion large airway collapse in CBE and MRIE

  12 months

• Exploring the diagnostic capacity of different exercise modalities to assess LAC

  12 months

Study Arms (1)

CBE & MRI

Forty healthy volunteers split in different age ranges (20-30 years n=10, 30-40 years n=10, 40-50 years n=10 and 50-60 years n=10) will undergo two airway assessments at rest and during exercise. The exercise assessments will be a continuous bronchoscopy during exercise (CBE-1st visit) and magnetic resonance imaging (MRI-2nd visit) separated by at least three days to ensure for a sufficient cardiorespiratory and musculoskeletal recovery.

Diagnostic Test: CBE & MRI

Interventions

CBE & MRI DIAGNOSTIC_TEST

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.

CBE & MRI

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects will be healthy and ≥ 20 to 60 years old. The total sample size will be 40 subjects. 10 for each age group (20-30; 30-40; 40-50; 50-60 years).

You may qualify if:

• Subjects will need to be within the age range of 20-60 years old
• have no known respiratory disease and normal spirometry
• be able to exercise without medical reason for limitation.

You may not qualify if:

• Subjects who have a significant comorbidity that prohibit exercise
• have had a respiratory infection within the last month
• known respiratory disease
• current smokers or are pregnant.

Sponsors & Collaborators

• Imperial College London: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Tracheobronchomalacia

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Bronchial Diseases; Respiratory Tract Diseases; Tracheal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• James Hull, Dr

  Royal Brompton Hospital-Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Hull, Dr

CONTACT

02073528121; j.hull@rbht.nhs.uk

Zander Williams, Mr

CONTACT

02073518029; z.williams@rbht.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: February 11, 2020
• Study Start: February 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)