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

Belfast Health and Social Care Trust33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Acute Lung Injury

Interventions

Aspirin 75mgDRUG

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 powderDRUG

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 1200mgDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Belfast Health and Social Care Trust

Belfast, United Kingdom

Outcomes

Primary Outcomes

Bronchoalveolar lavage IL-8 concentration

Time frame: 6 hrs after LPS inhalation

Secondary Outcomes

Alveolar inflammatory response biomarkers

Time frame: 6 hrs after LPS inhalation

Plasma inflammatory response biomarkers

Time frame: 6 and 24 hrs after LPS inhalation

Alveolar epithelial and endothelial function and injury biomarkers

Time frame: 6 hrs after LPS inhalation

Lipid inflammatory mediators

Time frame: 6 and 24 hrs after LPS inhalation

Data from ClinicalTrials.gov

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