Acute Lung Injury Clinical Trial
— ARENAOfficial title:
The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury
Verified date | September 2022 |
Source | Belfast Health and Social Care Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a double-blind, placebo-controled, randomized trial to investigate if aspirin pre-treatment has anti-inflammatory effects in a model of acute lung injury induced by inhaled endotoxin (LPS) in healthy human volunteers.
Status | Completed |
Enrollment | 33 |
Est. completion date | September 9, 2022 |
Est. primary completion date | September 9, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Healthy subjects Exclusion Criteria: - Age < 18 years - Pregnancy or breast feeding or woman of childbearing potential not using - adequate contraception. - Participation in a clinical trial of an investigational medicinal product within 30 days - Consent declined Aspirin or non steroidal anti-inflammatory (NSAID) use in the past 4 weeks - History of asthma - Known aspirin or NSAID hypersensitivity - History of peptic ulcer disease - Platelet count < 150 x 106/ml - Aspirin resistance |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Belfast Health and Social Care Trust | Belfast |
Lead Sponsor | Collaborator |
---|---|
Belfast Health and Social Care Trust | Northern Ireland Clinical Trials Unit, Queen's University, Belfast, The Intensive Care Society United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bronchoalveolar lavage IL-8 concentration | 6 hrs after LPS inhalation | ||
Secondary | Alveolar inflammatory response biomarkers | 6 hrs after LPS inhalation | ||
Secondary | Plasma inflammatory response biomarkers | 6 and 24 hrs after LPS inhalation | ||
Secondary | Alveolar epithelial and endothelial function and injury biomarkers | 6 hrs after LPS inhalation | ||
Secondary | Lipid inflammatory mediators | 6 and 24 hrs after LPS inhalation |
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