CopdPASSPORTNCT04716023
Physiology and Structure of the Small Airways in Patients With Chronic Airflow Obstruction or COVID-19
An observational study of Copd and COVID-19, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Aug 2019to 2 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects over the age of 16 with either chronic airflow obstruction or COVID-19
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Brompton
London
Christopher M Orton, MBBS, 02073518029 ext. 8029, c.orton@rbht.nhs.uk
About this study
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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, COVID-19, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Airflow obstruction / COVID-19 | Patients with either chronic airflow obstruction of COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, pre-procedure
Secondary outcomes (20)
Respiratory reactance at 5Hz: X5 (kPa/l/s)
Impulse Oscillometry
Measured: Baseline, pre-procedure
Reactance area: Ax (kPa/l/s)
Impulse Oscillometry
Measured: Baseline, pre-procedure
Functional residual capacity by MBNW: FRCgas (L)
Multiple Breath Nitrogen Washout
Measured: Baseline, pre-procedure
Lung clearance index: LCI
Multiple Breath Nitrogen Washout
Measured: Baseline, pre-procedure
Ventilation heterogeneity conducting airways: Scond (L/s)
Multiple Breath Nitrogen Washout
Measured: Baseline, pre-procedure
Ventilation heterogeneity acinar airways: Sacin (L/s)
Multiple Breath Nitrogen Washout
Measured: Baseline, pre-procedure
Forced expiratory volume in 1 second: FEV1 (L)
Spirometry
Measured: Baseline, pre-procedure
Forced vital capacity: FVC (L)
Spirometry
Measured: Baseline, pre-procedure
Total lung capacity: TLC (L)
Plethysmography
Measured: Baseline, pre-procedure
Residual volume: RV (L)
Plethysmography
Measured: Baseline, pre-procedure
Functional residual capacity by plethysmography: FRCpleth (L)
plethysmography
Measured: Baseline, pre-procedure
Airway mean luminal diameter (Dmean)
Optical Coherence Tomography
Measured: Baseline, during the procedure
Airway inner lumen area (Ai)
Optical Coherence Tomography
Measured: Baseline, during the procedure
Airway wall area (Aw), airway wall percentage (Aw%) as determined by [Aw/(Ai + Aw) × 100%]
Optical Coherence Tomography
Measured: Baseline, during the procedure
Air trapping - expiratory phase low attenuation area <856 HU (%LAA <856 HU)
Quantitative CT
Measured: Baseline, pre-procedure
Modified MRC dyspnoea score
Patient reported outcome measure
Measured: Baseline, pre-procedure
St George's Respiratory Questionnaire Score
Patient reported outcome measure
Measured: Baseline, pre-procedure
Asthma-related Quality of Life Questionnaire (AQLQ) (if asthmatic)
Patient reported outcome measure
Measured: Baseline, pre-procedure
Asthma Control Questionnaire (ACQ) (if asthmatic)
Patient reported outcome measure
Measured: Baseline, pre-procedure
6-minute walk distance (m)
6-minute walk distance (m)
Measured: Baseline, pre-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start23 Aug 2019
- Primary completion22 Aug 2021 (estimated)
- Study completion2 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716023
- Sponsor's protocol ID
- 18IC4688
- Acronym
- PASSPORT
- Status last verified
- Jan 2021
- First submitted
- 2 Jul 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiology and Structure of the Small Airways in Patients With Chronic Airflow Obstruction or COVID-19
- ClinicalTrials.gov ID
- NCT04716023
- Acronym / sponsor ID
- PASSPORT / 18IC4688
- Conditions
- Copd, COVID-19, Asthma, Small Airways Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 22 Aug 2021 (estimated)
- Study completion
- 2 Feb 2022 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Airflow obstruction / COVID-19 | – | –Patients with either chronic airflow obstruction of COVID-19 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects over the age of 16 with either chronic airflow obstruction or COVID-19
Key inclusion criteria (8 listed)
- Age 16 or over
- Scheduled for bronchoscopy as part of clinical care or research protocol
- No bleeding diathesis or therapeutic anticoagulation
- COPD:
- Diagnosed by standard clinical methods
Key exclusion criteria (12 listed)
- 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
- Contra-indications to passing oesophageal balloons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
20 secondary outcomes
Respiratory reactance at 5Hz: X5 (kPa/l/s)
Time frame: Baseline, pre-procedure
Reactance area: Ax (kPa/l/s)
Time frame: Baseline, pre-procedure
Functional residual capacity by MBNW: FRCgas (L)
Time frame: Baseline, pre-procedure
Lung clearance index: LCI
Time frame: Baseline, pre-procedure
Ventilation heterogeneity conducting airways: Scond (L/s)
Time frame: Baseline, pre-procedure
Ventilation heterogeneity acinar airways: Sacin (L/s)
Time frame: Baseline, pre-procedure
Forced expiratory volume in 1 second: FEV1 (L)
Time frame: Baseline, pre-procedure
Forced vital capacity: FVC (L)
Time frame: Baseline, pre-procedure
Total lung capacity: TLC (L)
Time frame: Baseline, pre-procedure
Residual volume: RV (L)
Time frame: Baseline, pre-procedure
Functional residual capacity by plethysmography: FRCpleth (L)
Time frame: Baseline, pre-procedure
Airway mean luminal diameter (Dmean)
Time frame: Baseline, during the procedure
Airway inner lumen area (Ai)
Time frame: Baseline, during the procedure
Airway wall area (Aw), airway wall percentage (Aw%) as determined by [Aw/(Ai + Aw) × 100%]
Time frame: Baseline, during the procedure
Air trapping - expiratory phase low attenuation area <856 HU (%LAA <856 HU)
Time frame: Baseline, pre-procedure
Modified MRC dyspnoea score
Time frame: Baseline, pre-procedure
St George's Respiratory Questionnaire Score
Time frame: Baseline, pre-procedure
Asthma-related Quality of Life Questionnaire (AQLQ) (if asthmatic)
Time frame: Baseline, pre-procedure
Asthma Control Questionnaire (ACQ) (if asthmatic)
Time frame: Baseline, pre-procedure
6-minute walk distance (m)
Time frame: Baseline, pre-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Copd and COVID-19, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher M Orton, MBBS (02073518029 ext. 8029, c.orton@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.