The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury (ARENA)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified July 2016 by Belfast Health and Social Care Trust
Sponsor:
Belfast Health and Social Care Trust
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
ClinicalTrials.gov Identifier:
NCT01659307
First received: August 4, 2012
Last updated: July 20, 2016
Last verified: July 2016
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Acute Lung Injury |
Drug: Aspirin 75mg Drug: Lactose powder Drug: Aspirin 1200mg |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury |
Resource links provided by NLM:
Drug Information available for:
Aspirin
Genetic and Rare Diseases Information Center resources:
Respiratory Distress Syndrome, Infant
Acute Respiratory Distress Syndrome
U.S. FDA Resources
Further study details as provided by Belfast Health and Social Care Trust:
Primary Outcome Measures:
- Bronchoalveolar lavage IL-8 concentration [ Time Frame: 6 hrs after LPS inhalation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Alveolar inflammatory response biomarkers [ Time Frame: 6 hrs after LPS inhalation ] [ Designated as safety issue: No ]
- Plasma inflammatory response biomarkers [ Time Frame: 6 and 24 hrs after LPS inhalation ] [ Designated as safety issue: No ]
- Alveolar epithelial and endothelial function and injury biomarkers [ Time Frame: 6 hrs after LPS inhalation ] [ Designated as safety issue: No ]
- Lipid inflammatory mediators [ Time Frame: 6 and 24 hrs after LPS inhalation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 33 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659307
Please refer to this study by its ClinicalTrials.gov identifier: 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):
| 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 |
| Study First Received: | August 4, 2012 |
| Last Updated: | July 20, 2016 |
| Health Authority: | United Kingdom: The Belfast Health and Social Care Trust United Kingdom: Office for Research Ethics Committees Northern Ireland United Kingdom: Medicine and Healthcare products Regulatory Agency United Kingdom: Queen's University Belfast |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 26, 2016