Biomarkers in respiratory immunology

Not Applicable

• Conditions: Respiratory infection and inflammation; Respiratory; Chronic lower respiratory diseases

• Registration Number: ISRCTN45524058
• Lead Sponsor: iverpool School of Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-21
• Last Update Posted: 4 September 2023
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 500

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.