Study of Inflammatory and Physiological Profiles of Healthy and Diseased Lung

Asthma Clinical Trial

— RETAIN  

Official title:

Study of Inflammatory and Physiological Profiles of Healthy and Diseased Lung

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06144476
• Other study ID #: 322540
• Status: Recruiting
• Start date: February 8, 2024
• Est. completion date: August 31, 2029

Study information

• Verified date: February 2024
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Gillian Radcliffe, MRes
• Phone: 02071888070
• Email: gillian.radcliffe[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: August 31, 2029
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Disease
• Asthma
• COPD

Locations

Country	Name	City	State
United Kingdom	Guy's & St Thomas' NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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