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

This study is currently recruiting participants.
Verified February 2017 by Professor Danny McAuley, Belfast Health and Social Care Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT01659307
First Posted: August 7, 2012
Last Update Posted: February 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
August 4, 2012
August 7, 2012
February 7, 2017
September 2012
August 2017   (Final data collection date for primary outcome measure)
Bronchoalveolar lavage IL-8 concentration [ Time Frame: 6 hrs after LPS inhalation ]
Same as current
Complete list of historical versions of study NCT01659307 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury
The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Acute Lung Injury
  • 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.
  • 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.
  • 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.
  • Active Comparator: Aspirin 75mg
    Aspirin 75mg once daily for 7 days. Administered by mouth.
    Intervention: Drug: Aspirin 75mg
  • Active Comparator: Aspirin 1200mg
    Asprin 600mg twice daily for 7 days. Administered by mouth.
    Intervention: Drug: Aspirin 1200mg
  • Placebo Comparator: Lactose powder
    Placebo for 7 days. Administered by mouth.
    Intervention: Drug: Lactose powder

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
33
August 2017
August 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact: Danny McAuley +442890 972144 d.f.mcauley@qub.ac.uk
United Kingdom
 
 
NCT01659307
11127DMcA-AS
2012-001589-13 ( EudraCT Number )
Yes
Not Provided
Not Provided
Professor Danny McAuley, Belfast Health and Social Care Trust
Belfast Health and Social Care Trust
  • The Intensive Care Society United Kingdom
  • Northern Ireland Clinical Trials Unit
  • Queen's University, Belfast
Principal Investigator: Danny McAuley Queens University, Belfast
Belfast Health and Social Care Trust
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP