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Physiology and Structure of the Small Airways in Patients With Chronic Airflow Obstruction or COVID-19 (PASSPORT)

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ClinicalTrials.gov Identifier: NCT04716023
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
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Brief Summary:
The purpose of this research project is to study small airways physiological function in patients with chronic obstructive lung disease or COVID-19 and explore the relationship with in-vivo microanatomical small airway structure as measured by OCT. Correlating endobronchial assessment with multiple breath nitrogen washout and impulse oscillometry will allow the characterisation of the relationship between small airway structural findings and these validated investigations. A small volume lung wash, endobronchial brushings and the collection of a limited number of endobronchial cryobiopsy samples will be performed to better understand the endobronchial environment of the small airways through inflammatory studies. Following the completion of any such work, residual samples will be stored in a "bio-bank" to enable the completion of future work. Understanding the relationship with symptom-based quality of life scoring questionnaires and a functional assessment of exercise capacity will help elucidate the clinical impact of in-vivo small airways findings.

Condition or disease
Copd COVID-19 Asthma Small Airways Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 42 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Physiology and Structure of the Small Airways in Patients With Chronic Airflow Obstruction or COVID-19
Actual Study Start Date : August 23, 2019
Estimated Primary Completion Date : August 22, 2021
Estimated Study Completion Date : February 2, 2022
Groups and Cohorts
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Group/Cohort
Chronic Airflow obstruction / COVID-19
Patients with either chronic airflow obstruction of COVID-19


Outcome Measures
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Primary Outcome Measures :
  1. Respiratory resistance at 5Hz - 20Hz (R5-R20) (kPa/l/s) related to airtrapping as determined by quantitative CT (Expiratory phase low attenuation area <856 HU (%LAA <856 HU) [ Time Frame: Baseline, pre-procedure ]
    Impulse Oscillometry


Secondary Outcome Measures :
  1. Respiratory reactance at 5Hz: X5 (kPa/l/s) [ Time Frame: Baseline, pre-procedure ]
    Impulse Oscillometry

  2. Reactance area: Ax (kPa/l/s) [ Time Frame: Baseline, pre-procedure ]
    Impulse Oscillometry

  3. Functional residual capacity by MBNW: FRCgas (L) [ Time Frame: Baseline, pre-procedure ]
    Multiple Breath Nitrogen Washout

  4. Lung clearance index: LCI [ Time Frame: Baseline, pre-procedure ]
    Multiple Breath Nitrogen Washout

  5. Ventilation heterogeneity conducting airways: Scond (L/s) [ Time Frame: Baseline, pre-procedure ]
    Multiple Breath Nitrogen Washout

  6. Ventilation heterogeneity acinar airways: Sacin (L/s) [ Time Frame: Baseline, pre-procedure ]
    Multiple Breath Nitrogen Washout

  7. Forced expiratory volume in 1 second: FEV1 (L) [ Time Frame: Baseline, pre-procedure ]
    Spirometry

  8. Forced vital capacity: FVC (L) [ Time Frame: Baseline, pre-procedure ]
    Spirometry

  9. Total lung capacity: TLC (L) [ Time Frame: Baseline, pre-procedure ]
    Plethysmography

  10. Residual volume: RV (L) [ Time Frame: Baseline, pre-procedure ]
    Plethysmography

  11. Functional residual capacity by plethysmography: FRCpleth (L) [ Time Frame: Baseline, pre-procedure ]
    plethysmography

  12. Airway mean luminal diameter (Dmean) [ Time Frame: Baseline, during the procedure ]
    Optical Coherence Tomography

  13. Airway inner lumen area (Ai) [ Time Frame: Baseline, during the procedure ]
    Optical Coherence Tomography

  14. Airway wall area (Aw), airway wall percentage (Aw%) as determined by [Aw/(Ai + Aw) × 100%] [ Time Frame: Baseline, during the procedure ]
    Optical Coherence Tomography

  15. Air trapping - expiratory phase low attenuation area <856 HU (%LAA <856 HU) [ Time Frame: Baseline, pre-procedure ]
    Quantitative CT

  16. Modified MRC dyspnoea score [ Time Frame: Baseline, pre-procedure ]
    Patient reported outcome measure

  17. St George's Respiratory Questionnaire Score [ Time Frame: Baseline, pre-procedure ]
    Patient reported outcome measure

  18. Asthma-related Quality of Life Questionnaire (AQLQ) (if asthmatic) [ Time Frame: Baseline, pre-procedure ]
    Patient reported outcome measure

  19. Asthma Control Questionnaire (ACQ) (if asthmatic) [ Time Frame: Baseline, pre-procedure ]
    Patient reported outcome measure

  20. 6-minute walk distance (m) [ Time Frame: Baseline, pre-procedure ]
    6-minute walk distance (m)


Other Outcome Measures:
  1. Exploratory: Inflammatory and pathological studies of airways brush, wash and cryobiopsy samples [ Time Frame: Baseline, during the procedure ]
    Laboratory based scientific studies


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects over the age of 16 with either chronic airflow obstruction or COVID-19
Criteria

Inclusion Criteria:

  1. Age 16 or over
  2. Scheduled for bronchoscopy as part of clinical care or research protocol
  3. No bleeding diathesis or therapeutic anticoagulation

  4. COPD:

    • FEV1/FVC ratio <70% or

Asthma:

  • Diagnosed by standard clinical methods
  • Post-bronchodilator FEV1 ≥60% predicted or COVID-19 infection or previous COVID-19 infection (confirmed as per local guidelines)

Exclusion Criteria:

  1. Unable to provide informed consent
  2. Exacerbation of obstructive airways disease or respiratory infection requiring systemic antibiotics or corticosteroids in the 6 weeks prior to enrolment unless suffering from COVID-19 infection and bronchoscopy is required for clinical reasons

  3. Contra-indications to performing lung function testing

    • Aortic aneurysm >6cm
    • Unstable cardiovascular disease (unstable angina, myocardial infarction or pulmonary embolism <4 weeks prior)
    • Severe aortic stenosis
    • Pneumothorax
    • Cerebral aneurysm
    • Thoracic or abdominal surgery <4 weeks prior

  4. Contra-indications to passing oesophageal balloons

    • Oesophageal ulceration or varices
    • Sinusitis, recent nasal surgery or epistaxis
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716023


Contacts
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Contact: Christopher M Orton, MBBS 02073518029 ext 8029 c.orton@rbht.nhs.uk

Locations
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United Kingdom
The Royal Brompton Recruiting
London, United Kingdom
Contact: Christopher M Orton, MBBS    02073518029 ext 8029    c.orton@rbht.nhs.uk   
Sponsors and Collaborators
Imperial College London
More Information
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04716023    
Other Study ID Numbers: 18IC4688
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases