A study of bronchoscopic biomarkers in respiratory immunology

iverpool School of Tropical Medicine0 sites500 target enrollmentNovember 21, 2018

Overview

No summary available.

Registry

who.int

Start Date

November 21, 2018

End Date

November 1, 2028

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

•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

•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)