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

NCT04716023 | Unknown DMC

• 1 other identifier: 18IC4688
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Copd; COVID-19; Asthma; Small Airways Disease

Outcome Measures

Primary Outcomes (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)

  Impulse Oscillometry

  Baseline, pre-procedure

Secondary Outcomes (20)

• Respiratory reactance at 5Hz: X5 (kPa/l/s)

  Baseline, pre-procedure

• Reactance area: Ax (kPa/l/s)

  Baseline, pre-procedure

• Functional residual capacity by MBNW: FRCgas (L)

  Baseline, pre-procedure

• Lung clearance index: LCI

  Baseline, pre-procedure

• Ventilation heterogeneity conducting airways: Scond (L/s)

  Baseline, pre-procedure

Other Outcomes (1)

• Exploratory: Inflammatory and pathological studies of airways brush, wash and cryobiopsy samples

  Baseline, during the procedure

Study Arms (1)

Chronic Airflow obstruction / COVID-19

Patients with either chronic airflow obstruction of COVID-19

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects over the age of 16 with either chronic airflow obstruction or COVID-19

You may qualify if:

• Age 16 or over
• Scheduled for bronchoscopy as part of clinical care or research protocol
• No bleeding diathesis or therapeutic anticoagulation
• 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)

You may not qualify if:

• Unable to provide informed consent
• 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
• 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
• Contra-indications to passing oesophageal balloons
• Oesophageal ulceration or varices
• Sinusitis, recent nasal surgery or epistaxis

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

The Royal Brompton

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; COVID-19; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Christopher M Orton, MBBS

CONTACT

02073518029; c.orton@rbht.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: January 20, 2021
• Study Start: August 23, 2019
• Primary Completion: August 22, 2021
• Study Completion: February 2, 2022
• Last Updated: January 20, 2021

Record last verified: 2021-01

Locations

GB (1)