The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury (ARENA)
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ClinicalTrials.gov Identifier: NCT01659307 |
Recruitment Status
:
Recruiting
First Posted
: August 7, 2012
Last Update Posted
: February 7, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Lung Injury | Drug: Aspirin 75mg Drug: Lactose powder Drug: Aspirin 1200mg | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 33 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury |
Study Start Date : | September 2012 |
Estimated Primary Completion Date : | August 2017 |
Estimated Study Completion Date : | August 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Aspirin 75mg
Aspirin 75mg once daily for 7 days. Administered by mouth.
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Drug: 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.
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Active Comparator: Aspirin 1200mg
Asprin 600mg twice daily for 7 days. Administered by mouth.
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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.
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Placebo Comparator: Lactose powder
Placebo for 7 days. Administered by mouth.
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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.
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- Bronchoalveolar lavage IL-8 concentration [ Time Frame: 6 hrs after LPS inhalation ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659307
Contact: Danny McAuley | +442890 972144 | d.f.mcauley@qub.ac.uk |
United Kingdom | |
Belfast Health and Social Care Trust | Recruiting |
Belfast, United Kingdom | |
Contact: Danny McAuley +442890 972144 d.f.mcauley@qub.a.uk |
Principal Investigator: | Danny McAuley | Queens University, Belfast |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Professor Danny McAuley, Professor of Intensive care Medicine, Belfast Health and Social Care Trust |
ClinicalTrials.gov Identifier: | NCT01659307 History of Changes |
Other Study ID Numbers: |
11127DMcA-AS 2012-001589-13 ( EudraCT Number ) |
First Posted: | August 7, 2012 Key Record Dates |
Last Update Posted: | February 7, 2017 |
Last Verified: | February 2017 |
Keywords provided by Professor Danny McAuley, Belfast Health and Social Care Trust:
Acute Lung Injury Acute Respiratory Distress Syndrome Aspirin |
Additional relevant MeSH terms:
Thoracic Injuries Wounds and Injuries Inflammation Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Pathologic Processes Lung Diseases Respiratory Tract Diseases Respiration Disorders Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |