Respiratory infection and inflammation Respiratory Chronic lower respiratory diseases
Conditions
Interventions
Participants will attend a bronchoscopy appointment. Fibreoptic bronchoscopy will be performed via a nasal or oral route using a standard operating procedure. Participants will fast for at least 4 hou
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Capacity to provide written consent before any study procedures are performed and can understand and comply with the requirements of the study. 2. Males and non-pregnant females 3. Aged 18-85 years 4. Fluent in English, able to understand the procedures and convey any adverse events effectively to the research team
Exclusion criteria
Exclusion criteria: Any of the following will exclude participants from the study: 1. Uncontrolled medical or surgical conditions that may preclude nasal or oral intubation with a bronchoscope or the bronchoscopy itself, in the opinion of the investigator 2. Any report of acute illness or febrile event that has not resolved 72 hours before bronchoscopy 3. Previous adverse reactions to benzodiazepines or anaesthetic agents (lidocaine) including reversal agents such as flumazenil 4. Participated (taken investigative drug and/or device) in another clinical trial within 1 month or within drug’s 5 half-lives, whichever is longer, before the study procedure (this is not relevant to participants in an EHPC study) 5. Full blood count, clotting or renal function level outside of normal range and deemed as clinically significant by the investigator 6. Very poor venous access 7. Not abstained from alcoholic beverages or alcohol-containing products for at least 24 hours before bronchoscopy 8. Receipt of blood products within 2 months prior to screening 9. Should not participate in this study for their own safety in the opinion of the Investigator (or designee) Exclusion criteria for participants with acute or chronic respiratory disease such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, bronchiectasis, pneumonia or lower respiratory tract infection: 1. Unable to perform spirometry (spirometry must be within 6 months prior to screening) 2. On long term oxygen therapy (LTOT) 3. Oxygen saturations on screening of <92% on air 4. Any uncontrolled medical or surgical condition as deemed clinically significant by the CI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune responses in the lungs of healthy participants compared to different patient groups, assessed by bronchoalveolar lavage (BAL) and blood using lung biomarker levels at the time of bronchoscopic sampling. Since this is an exploratory study the precise methods of measurement will be defined after the initial 50 study participants samples have been taken. | — |
Secondary
| Measure | Time frame |
|---|---|
| Since this is an exploratory study the precise methods of measurement will be defined after the initial 50 study participants samples have been taken, and re-defined as required. 1. Bacterial/viral aspiration in the lung, assessed by bronchoalveolar lavage (BAL) using classical microbiological/virological techniques on samples taken at screening and at the time of bronchoscopic sampling 2. Biomarkers of respiratory colonisation, assessed by laboratory analysis on samples taken at screening and at the time of bronchoscopic sampling 3. Effectiveness of bronchoabsorption technique to assess inflammation and infection in healthy participants and different patient groups, assessed by laboratory analysis on samples taken at the time of bronchoscopic sampling 4. Upper and lower airway microbiome in healthy participants and different patient groups, assessed using laboratory techniques at screening and at the time of bronchoscopic sampling 5. Opsonophagocytic bacterial killing activity (OPKA) in healthy participants and different patient groups, assessed using laboratory OPKA assays on samples taken at screening and at the time of bronchoscopic sampling 6. Bacterial and viral specific immune responses in the lung, assessed using laboratory assays on samples taken at screening and at the time of bronchoscopic sampling | — |
Countries
England, United Kingdom
Outcome results
None listed