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

Asthma Clinical Trial

— PASSPORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04716023
• Other study ID #: 18IC4688
• Status: Recruiting
• Start date: August 23, 2019
• Est. completion date: February 2, 2022

Study information

• Verified date: January 2021
• Source: Imperial College London
• Contact: Christopher M Orton, MBBS
• Phone: 02073518029
• Email: c.orton[@]rbht.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: February 2, 2022
• Est. primary completion date: August 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Copd
• COVID-19
• Pulmonary Disease, Chronic Obstructive
• Small Airways Disease

Locations

Country	Name	City	State
United Kingdom	The Royal Brompton	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory: Inflammatory and pathological studies of airways brush, wash and cryobiopsy samples	Laboratory based scientific studies	Baseline, during the procedure
Primary	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	Respiratory reactance at 5Hz: X5 (kPa/l/s)	Impulse Oscillometry	Baseline, pre-procedure
Secondary	Reactance area: Ax (kPa/l/s)	Impulse Oscillometry	Baseline, pre-procedure
Secondary	Functional residual capacity by MBNW: FRCgas (L)	Multiple Breath Nitrogen Washout	Baseline, pre-procedure
Secondary	Lung clearance index: LCI	Multiple Breath Nitrogen Washout	Baseline, pre-procedure
Secondary	Ventilation heterogeneity conducting airways: Scond (L/s)	Multiple Breath Nitrogen Washout	Baseline, pre-procedure
Secondary	Ventilation heterogeneity acinar airways: Sacin (L/s)	Multiple Breath Nitrogen Washout	Baseline, pre-procedure
Secondary	Forced expiratory volume in 1 second: FEV1 (L)	Spirometry	Baseline, pre-procedure
Secondary	Forced vital capacity: FVC (L)	Spirometry	Baseline, pre-procedure
Secondary	Total lung capacity: TLC (L)	Plethysmography	Baseline, pre-procedure
Secondary	Residual volume: RV (L)	Plethysmography	Baseline, pre-procedure
Secondary	Functional residual capacity by plethysmography: FRCpleth (L)	plethysmography	Baseline, pre-procedure
Secondary	Airway mean luminal diameter (Dmean)	Optical Coherence Tomography	Baseline, during the procedure
Secondary	Airway inner lumen area (Ai)	Optical Coherence Tomography	Baseline, during the procedure
Secondary	Airway wall area (Aw), airway wall percentage (Aw%) as determined by [Aw/(Ai + Aw) × 100%]	Optical Coherence Tomography	Baseline, during the procedure
Secondary	Air trapping - expiratory phase low attenuation area <856 HU (%LAA <856 HU)	Quantitative CT	Baseline, pre-procedure
Secondary	Modified MRC dyspnoea score	Patient reported outcome measure	Baseline, pre-procedure
Secondary	St George's Respiratory Questionnaire Score	Patient reported outcome measure	Baseline, pre-procedure
Secondary	Asthma-related Quality of Life Questionnaire (AQLQ) (if asthmatic)	Patient reported outcome measure	Baseline, pre-procedure
Secondary	Asthma Control Questionnaire (ACQ) (if asthmatic)	Patient reported outcome measure	Baseline, pre-procedure
Secondary	6-minute walk distance (m)	6-minute walk distance (m)	Baseline, pre-procedure