Study of Inflammatory and Physiological Profiles of Healthy and Diseased Lung (RETAIN)

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma; COPD; 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

1. Disease specific questionnaires.
2. Lung function tests including spirometry or oscillometry (if not performed previously within 6 months)
3. Sputum collection
4. Nasal sampling including nasosorption, nasal brushing, nasal lavage, or nasopharyngeal swabs
5. Exhaled breath

6. Blood samples (<6 tablespoons)

   Optional

7. Bronchoscopy involving a flexible fibreoptic camera passed into the lungs to collect bronchoalveolar lavage, bronchosorption, bronchial brushings and bronchial biopsies.
8. To repeat these procedures at later time - expected once per year or at times of clinically relevant changes

• Study Type: Observational
• Enrollment (Estimated): 230

Contacts and Locations

• Study Contact: Name: Gillian Radcliffe, MRes; Phone Number: 02071888070; Email: gillian.radcliffe@gstt.nhs.uk
• Study Contact Backup: Name: Steven Cass, PhD; Email: steven.cass@kcl.ac.uk

Study Locations

• United Kingdom
  • London
    • London, London, United Kingdom, SE1 9RT
      • Recruiting
      • Guy's & St Thomas' NHS Foundation Trust
      • Contact: Gill Radcliffe; Phone Number: 02071888070; Email: gillian.radcliffe@gstt.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study will include patients diagnosed or with suspected COPD and asthma. The study will include both current and former smokers.

Description

Inclusion Criteria:

• 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.)

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Airways Disease; Patients with or suspected airways disease including COPD or asthma
Healthy Volunteers; Participants with no significant illness

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 years

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London
• Investigators: Principal Investigator: Mona Bafadhel, Prof, GSTT and KCL

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Pulmonary Disease; Airway Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pathological Conditions, Signs and Symptoms; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Asthma
• Other Study ID Numbers: 322540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No