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Recruiting

NCT Number: NCT06144476

Study of Inflammatory and Physiological Profiles of Healthy and Diseased Lung

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guy's & St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location status: Recruiting

Location contact

Gill Radcliffe

CONTACT

[email protected]

02071888070

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Blood samples for stability of airway disease immune endotypes

    Time frame: 6 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gillian Radcliffe, MRes

CONTACT

[email protected]

02071888070

Steven Cass, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • King's College London

Registry information

Acronym: RETAIN

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Nov 22, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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