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

See Contacts and Locations

Sponsor:

Collaborators:

The Intensive Care Society United Kingdom

Northern Ireland Clinical Trials Unit

Queen's University, Belfast

Information provided by (Responsible Party):

Professor Danny McAuley, Belfast Health and Social Care Trust

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Lung Injury	Drug: Aspirin 75mg Drug: Lactose powder Drug: Aspirin 1200mg	Phase 2

Study Design


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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Aspirin 75mg Aspirin 75mg once daily for 7 days. Administered by mouth.	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.
Active Comparator: Aspirin 1200mg Asprin 600mg twice daily for 7 days. Administered by mouth.	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.
Placebo Comparator: Lactose powder Placebo for 7 days. Administered by mouth.	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.

Outcome Measures

Primary Outcome Measures :

Bronchoalveolar lavage IL-8 concentration [ Time Frame: 6 hrs after LPS inhalation ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Contacts


Contact: Danny McAuley	+442890 972144	d.f.mcauley@qub.ac.uk

Locations


United Kingdom
Belfast Health and Social Care Trust	Recruiting
Belfast, United Kingdom
Contact: Danny McAuley +442890 972144 d.f.mcauley@qub.a.uk

Sponsors and Collaborators

Belfast Health and Social Care Trust

The Intensive Care Society United Kingdom

Northern Ireland Clinical Trials Unit

Queen's University, Belfast

Investigators


Principal Investigator:	Danny McAuley	Queens University, Belfast

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hamid U, Krasnodembskaya A, Fitzgerald M, Shyamsundar M, Kissenpfennig A, Scott C, Lefrancais E, Looney MR, Verghis R, Scott J, Simpson AJ, McNamee J, McAuley DF, O'Kane CM. Aspirin reduces lipopolysaccharide-induced pulmonary inflammation in human models of ARDS. Thorax. 2017 Nov;72(11):971-980. doi: 10.1136/thoraxjnl-2016-208571. Epub 2017 Jan 12.

Toner P, McAuley DF, Shyamsundar M. Aspirin as a potential treatment in sepsis or acute respiratory distress syndrome. Crit Care. 2015 Oct 23;19:374. doi: 10.1186/s13054-015-1091-6. Review.

Curley GF, McAuley DF. Stem cells for respiratory failure. Curr Opin Crit Care. 2015 Feb;21(1):42-9. doi: 10.1097/MCC.0000000000000171. Review.


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

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