COPDRETAINNCT06144476
Study of Inflammatory and Physiological Profiles of Healthy and Diseased Lung
An observational study of COPD and Asthma, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
There are over 700,000 UK hospital admissions every year with lung disease symptoms. Two of the most common lung diseases contributing to these numbers are asthma and chronic obstructive pulmonary disease (COPD). The immunopathology of these diseases is not fully understood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Asthma, Airway Disease
- How many people
- 230 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Feb 2024to 31 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include patients diagnosed or with suspected COPD and asthma. The study will include both current and former smokers.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study
- Aged 18 years or above
- Patient: known or suspected airway disease
- Healthy volunteer: considered to be in good health with no significant comorbidity (immune disorder, cancer etc.)
Who cannot join
- Known or suspected current pulmonary tuberculosis, HIV (human immunodeficiency virus), Hepatitis B Virus, Hepatitis C Virus.
- Surgery within the preceding 6 weeks
- Participants who are pregnant
- History of psychiatric, medical, or surgical disorders that in the opinion of the chief investigator may interfere with sample collection, undergo a bronchoscopy, or may compromise study completion or data collection
- Alcohol or recreational drug abuse
- Diagnosis of immunodeficiency requiring treatment
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- Unable to provide written informed consent
- Unable to read or write English
- Be considered, in the opinion of the investigator, to be an unsuitable candidate for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Steven Cass, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's & St Thomas' NHS Foundation Trust
London, London, SE1 9RT
Gill Radcliffe, 02071888070, gillian.radcliffe@gstt.nhs.uk
About this study
There are over 700,000 UK hospital admissions every year with lung disease symptoms. Two of the most common lung diseases contributing to these numbers are asthma and chronic obstructive pulmonary disease (COPD). The immunopathology of these diseases is not fully understood. Matched samples from the respiratory tract and circulation will be used to identify immune patterns throughout the respiratory system to elucidate the immunopathology of airway disease.
Read the detailed description
In this observational study, we will be enrolling patients with diagnosed or suspected airways disease who are over 18 years old, as well as age matched healthy volunteers with no significant illness. Participants will be asked if they consent to enter the study, invited at clinically relevant time points (treatment change, disease exacerbation etc.) and to optional bronchoscopy visits. It is expected that participants will be seen yearly with any additional exacerbation/treatment visits also recorded. Research visits will occur at King's College London and the Guys and St Thomas' NHS Foundation Trust (GSTFT), with all bronchoscopy visits occurring within GSTFT
- Disease specific questionnaires.
- Lung function tests including spirometry or oscillometry (if not performed previously within 6 months)
- Sputum collection
- Nasal sampling including nasosorption, nasal brushing, nasal lavage, or nasopharyngeal swabs
- Exhaled breath
- Blood samples (<6 tablespoons) Optional
- Bronchoscopy involving a flexible fibreoptic camera passed into the lungs to collect bronchoalveolar lavage, bronchosorption, bronchial brushings and bronchial biopsies.
- To repeat these procedures at later time - expected once per year or at times of clinically relevant changes
- Conditions
- COPD, Asthma, Airway Disease
- Keywords
- Airway Disease, Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Lung Diseases
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 |
|---|---|---|
| Airways Disease | Patients with or suspected airways disease including COPD or asthma | |
| Healthy Volunteers | Participants with no significant illness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood samples for presence of airway disease immune endotypes
Blood samples taken to assess inflammatory mediators to determine airway disease severity. Physiological and inflammatory characterisation of participants with known or suspected airway disease at stable state, compared to healthy volunteers with the aim to identify distinct immune endotypes in airways disease
Measured: 6 years
Secondary outcomes (1)
Blood samples for stability of airway disease immune endotypes
To assess the stability of blood inflammatory mediators to identify continuing airway disease endotypes. Longitudinal analysis of physiological and inflammatory characteristics in participants with known or suspected airway disease at stable state, compared to healthy volunteers over time.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start8 Feb 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2029 (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 Guy's and St Thomas' NHS Foundation TrustThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Mona Bafadhel, Prof, Principal investigator, GSTT and KCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144476
- Sponsor's protocol ID
- 322540
- Acronym
- RETAIN
- Status last verified
- Jun 2026
- First submitted
- 22 Aug 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Inflammatory and Physiological Profiles of Healthy and Diseased Lung
- ClinicalTrials.gov ID
- NCT06144476
- Acronym / sponsor ID
- RETAIN / 322540
- Conditions
- COPD, Asthma, Airway Disease
- Keywords
- Airway Disease, Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 22 Nov 2023 (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.
There are over 700,000 UK hospital admissions every year with lung disease symptoms. Two of the most common lung diseases contributing to these numbers are asthma and chronic obstructive pulmonary disease (COPD). The immunopathology of these diseases is not fully understood. Matched samples from the respiratory tract and circulation will be used to identify immune patterns throughout the respiratory system to elucidate the immunopathology of airway disease.
Detailed description
In this observational study, we will be enrolling patients with diagnosed or suspected airways disease who are over 18 years old, as well as age matched healthy volunteers with no significant illness. Participants will be asked if they consent to enter the study, invited at clinically relevant time points (treatment change, disease exacerbation etc.) and to optional bronchoscopy visits. It is expected that participants will be seen yearly with any additional exacerbation/treatment visits also recorded. Research visits will occur at King's College London and the Guys and St Thomas' NHS Foundation Trust (GSTFT), with all bronchoscopy visits occurring within GSTFT
- Disease specific questionnaires.
- Lung function tests including spirometry or oscillometry (if not performed previously within 6 months)
- Sputum collection
- Nasal sampling including nasosorption, nasal brushing, nasal lavage, or nasopharyngeal swabs
- Exhaled breath
- Blood samples (<6 tablespoons) Optional
- Bronchoscopy involving a flexible fibreoptic camera passed into the lungs to collect bronchoalveolar lavage, bronchosorption, bronchial brushings and bronchial biopsies.
- To repeat these procedures at later time - expected once per year or at times of clinically relevant changes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airways Disease | – | –Patients with or suspected airways disease including COPD or asthma |
| Healthy Volunteers | – | –Participants with no significant illness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients diagnosed or with suspected COPD and asthma. The study will include both current and former smokers.
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study
- Aged 18 years or above
- Patient: known or suspected airway disease
- Healthy volunteer: considered to be in good health with no significant comorbidity (immune disorder, cancer etc.)
Key exclusion criteria (9 listed)
- Known or suspected current pulmonary tuberculosis, HIV (human immunodeficiency virus), Hepatitis B Virus, Hepatitis C Virus.
- Surgery within the preceding 6 weeks
- Participants who are pregnant
- History of psychiatric, medical, or surgical disorders that in the opinion of the chief investigator may interfere with sample collection, undergo a bronchoscopy, or may compromise study completion or data collection
- Alcohol or recreational drug abuse
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
Blood samples for presence of airway disease immune endotypes
Time frame: 6 years
Blood samples taken to assess inflammatory mediators to determine airway disease severity. Physiological and inflammatory characterisation of participants with known or suspected airway disease at stable state, compared to healthy volunteers with the aim to identify distinct immune endotypes in airways disease
1 secondary outcome
Blood samples for stability of airway disease immune endotypes
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Steven Cass, PhD contact
Mona Bafadhel, Prof principal investigator
GSTT and KCL
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 Asthma, run by Guy's and St Thomas' NHS Foundation Trust 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gillian Radcliffe, MRes (02071888070, gillian.radcliffe@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood samples for presence of airway disease immune endotypes (time frame: 6 years). 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 4 Jun 2026.