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

Belfast Health and Social Care Trust

Status and phase: Completed; Phase 2

Conditions: Acute Lung Injury

Treatments: Drug: Lactose powder; Drug: Aspirin 75mg; Drug: Aspirin 1200mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01659307

2012-001589-13 (EudraCT Number)

11127DMcA-AS

Details and patient eligibility

About

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.

Enrollment: 33 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 3 patient groups, including a placebo group

Aspirin 75mg

Active Comparator group

Description:

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

Treatment:

Drug: Aspirin 75mg

Aspirin 1200mg

Active Comparator group

Description:

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

Treatment:

Drug: Aspirin 1200mg

Lactose powder

Placebo Comparator group

Description:

Placebo for 7 days. Administered by mouth.

Treatment:

Drug: Lactose powder