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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. (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

August 4, 2012
April 23, 2013
September 2012
August 2014   (final data collection date for primary outcome measure)
Bronchoalveolar lavage IL-8 concentration [ Time Frame: 6 hrs after LPS inhalation ] [ Designated as safety issue: No ]
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 ] [ 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 ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
33
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Danny McAuley +442890 972144 d.f.mcauley@qub.ac.uk
United Kingdom
 
NCT01659307
11127DMcA-AS, 2012-001589-13
Yes
Professor Danny McAuley, Belfast Health and Social Care Trust
Belfast Health and Social Care Trust
  • United Kingdom Intensive Care Society
  • Northern Ireland Clinical Research Support Centre
  • Queen's University, Belfast
Principal Investigator: Danny McAuley Queens University, Belfast
Belfast Health and Social Care Trust
April 2013

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