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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Lung Injury

Intervention / Treatment
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* Drug: Aspirin 75mg
* Drug: Lactose powder
* Drug: Aspirin 1200mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspirin 75mg<br>Aspirin 75mg once daily for 7 days. Administered by mouth. | Drug: Aspirin 75mg<br>* 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.<br>|
| Active Comparator: Aspirin 1200mg<br>Asprin 600mg twice daily for 7 days. Administered by mouth. | Drug: Aspirin 1200mg<br>* 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.<br>|
| Placebo Comparator: Lactose powder<br>Placebo for 7 days. Administered by mouth. | Drug: Lactose powder<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchoalveolar lavage IL-8 concentration |  | 6 hrs after LPS inhalation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolar inflammatory response biomarkers |  | 6 hrs after LPS inhalation | 
| Plasma inflammatory response biomarkers |  | 6 and 24 hrs after LPS inhalation | 
| Alveolar epithelial and endothelial function and injury biomarkers |  | 6 hrs after LPS inhalation | 
| Lipid inflammatory mediators |  | 6 and 24 hrs after LPS inhalation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Lung Injury, Acute Respiratory Distress Syndrome, Aspirin