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NCT01659307 Clinical Trial

The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury

Acute Lung Injury Clinical Trial

— ARENA  

Official title:
The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01659307
Other study ID # 11127DMcA-AS
Secondary ID 2012-001589-13
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2012
Est. completion date September 9, 2022

Study information
Verified date September 2022
Source Belfast Health and Social Care Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Aspirin 75mg
Subjects randomised to aspirin 75mg will receive 1 container containing aspirin 75mg and 1 container containing placebo for the morning and 2 containers containing placebo for the evening. Subjects will take one capsule from each container in the morning and one capsule from each container in the evening.
• Lactose powder
Subjects randomised to placebo will receive 4 containers of placebo, 2 containers containing placebo for the morning and 2 containers containing placebo for the evening. Subjects will take one capsule from each container in the morning and one capsule from each container in the evening.
• Aspirin 1200mg
Subjects randomised to aspirin 600mg 12 hourly will receive 2 containers of aspirin 300mg each for the morning and 2 containers of aspirin 300mg each for the evening. Subjects will take one capsule from each container in the morning and one capsule from each container in the evening.

Locations
Country Name City State
United Kingdom Belfast Health and Social Care Trust Belfast

Sponsors (4)
Lead Sponsor Collaborator
Belfast Health and Social Care Trust Northern Ireland Clinical Trials Unit, Queen's University, Belfast, The Intensive Care Society United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome
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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