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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04716023
Acronym
PASSPORT
Enrollment
42
Registered
2021-01-20
Start date
2019-08-23
Completion date
2022-02-02
Last updated
2021-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Copd, COVID-19, Small Airways Disease

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.

Interventions

None listed

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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)Baseline, pre-procedureImpulse Oscillometry

Secondary

MeasureTime frameDescription
Functional residual capacity by MBNW: FRCgas (L)Baseline, pre-procedureMultiple Breath Nitrogen Washout
Lung clearance index: LCIBaseline, pre-procedureMultiple Breath Nitrogen Washout
Respiratory reactance at 5Hz: X5 (kPa/l/s)Baseline, pre-procedureImpulse Oscillometry
Ventilation heterogeneity conducting airways: Scond (L/s)Baseline, pre-procedureMultiple Breath Nitrogen Washout
Ventilation heterogeneity acinar airways: Sacin (L/s)Baseline, pre-procedureMultiple Breath Nitrogen Washout
Forced expiratory volume in 1 second: FEV1 (L)Baseline, pre-procedureSpirometry
Forced vital capacity: FVC (L)Baseline, pre-procedureSpirometry
Total lung capacity: TLC (L)Baseline, pre-procedurePlethysmography
Residual volume: RV (L)Baseline, pre-procedurePlethysmography
Reactance area: Ax (kPa/l/s)Baseline, pre-procedureImpulse Oscillometry
Airway mean luminal diameter (Dmean)Baseline, during the procedureOptical Coherence Tomography
Airway inner lumen area (Ai)Baseline, during the procedureOptical Coherence Tomography
Airway wall area (Aw), airway wall percentage (Aw%) as determined by [Aw/(Ai + Aw) × 100%]Baseline, during the procedureOptical Coherence Tomography
Air trapping - expiratory phase low attenuation area <856 HU (%LAA <856 HU)Baseline, pre-procedureQuantitative CT
Modified MRC dyspnoea scoreBaseline, pre-procedurePatient reported outcome measure
St George's Respiratory Questionnaire ScoreBaseline, pre-procedurePatient reported outcome measure
Asthma-related Quality of Life Questionnaire (AQLQ) (if asthmatic)Baseline, pre-procedurePatient reported outcome measure
Asthma Control Questionnaire (ACQ) (if asthmatic)Baseline, pre-procedurePatient reported outcome measure
6-minute walk distance (m)Baseline, pre-procedure6-minute walk distance (m)
Functional residual capacity by plethysmography: FRCpleth (L)Baseline, pre-procedureplethysmography

Other

MeasureTime frameDescription
Exploratory: Inflammatory and pathological studies of airways brush, wash and cryobiopsy samplesBaseline, during the procedureLaboratory based scientific studies

Countries

United Kingdom

Contacts

Primary ContactChristopher M Orton, MBBS
c.orton@rbht.nhs.uk02073518029

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026