Study of Inflammatory and Physiological Profiles of Healthy and Diseased Lung
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: COPD, Asthma, Airway Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Primary outcome measures
- Blood samples for presence of airway disease immune endotypes [Time frame: 6 years]
Secondary outcome measures (1)
- Blood samples for stability of airway disease immune endotypes [Time frame: 6 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Guy's & St Thomas' NHS Foundation Trust — London
Identifiers
NCT: NCT06144476 · 322540