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 April 2013 by Belfast Health and Social Care Trust
Sponsor:
Collaborators:
United Kingdom Intensive Care Society
Northern Ireland Clinical Research Support Centre
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: April 23, 2013
Last verified: April 2013
  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:


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 2014
Estimated Primary Completion Date: August 2014 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy non-smoking 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

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
United Kingdom Intensive Care Society
Northern Ireland Clinical Research Support Centre
Queen's University, Belfast
Investigators
Principal Investigator: Danny McAuley Queens University, Belfast
  More Information

No publications provided

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: April 23, 2013
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
Inflammation
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Wounds and Injuries
Respiration Disorders
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on September 29, 2014