Study of Inflammatory and Physiological Profiles of Healthy and Diseased Lung

NCT06144476 | Recruiting

• 1 other identifier: 322540
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; Asthma; Airway Disease

Keywords

Airway Disease; Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Blood samples for stability of airway disease immune endotypes

  6 years

Study Arms (2)

Airways Disease

Patients with or suspected airways disease including COPD or asthma

Healthy Volunteers

Participants with no significant illness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

Guy's & St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

All samples will be collected for exploratory research including future genetic/DNA research. Sputum: Phosphate buffered saline (PBS) and dithiothreitol (DTT) sputum supernatant, Sputum cell cytospins, Sputum cellular pellet Nasal: Nasosorption swabs, Nasopharyngeal swabs, Nasal lavage, Nasal brushings Breath: Exhaled Breath Blood: Whole blood, Blood cells, Serum/plasma Bronchoscopy: Bronchial biopsies, Bronchial lavage, Bronchosorption swabs, Bronchial brushings

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Lung Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Mona Bafadhel, Prof

  GSTT and KCL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gillian Radcliffe, MRes

CONTACT

02071888070; gillian.radcliffe@gstt.nhs.uk

Steven Cass, PhD

CONTACT

steven.cass@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: November 22, 2023
• Study Start: February 8, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2029
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)