Clinical trial NCT06144476: Study of Inflammatory and Physiological Profiles of Healthy and Diseased Lung
Official title: Study of Inflammatory and Physiological Profiles of Healthy and Diseased Lung
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
Asthma
Airway Disease
Keywords: Airway Disease
Pulmonary Disease
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2023-11-22
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Blood samples for presence of airway disease immune endotypes
timeFrame: 6 years
Secondary outcomes:
measure: Blood samples for stability of airway disease immune endotypes
timeFrame: 6 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
Study officials:
affiliation: GSTT and KCL
name: Mona Bafadhel, Prof
role: PRINCIPAL_INVESTIGATOR
References: