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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01659307

Acronym

ARENA

Enrollment

Registered

2012-08-07

Start date

2012-09-30

Completion date

2022-09-09

Last updated

2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lung Injury

Keywords

Acute Lung Injury, Acute Respiratory Distress Syndrome, Aspirin

Brief 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.

Interventions

DRUGAspirin 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.

DRUGLactose 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.

DRUGAspirin 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bronchoalveolar lavage IL-8 concentration	6 hrs after LPS inhalation

Secondary

Measure	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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026