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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2022-09-09

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.

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Detailed Description

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Conditions

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Acute Lung Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aspirin 75mg

Aspirin 75mg once daily for 7 days. Administered by mouth.

Group Type ACTIVE_COMPARATOR

Aspirin 75mg

Intervention Type DRUG

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.

Aspirin 1200mg

Asprin 600mg twice daily for 7 days. Administered by mouth.

Group Type ACTIVE_COMPARATOR

Aspirin 1200mg

Intervention Type DRUG

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.

Lactose powder

Placebo for 7 days. Administered by mouth.

Group Type PLACEBO_COMPARATOR

Lactose powder

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes