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

Primary Purpose

Acute Lung Injury

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Aspirin 75mg
Lactose powder
Aspirin 1200mg
Sponsored by
Belfast Health and Social Care Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Lung Injury focused on measuring Acute Lung Injury, Acute Respiratory Distress Syndrome, Aspirin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Belfast Health and Social Care Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Aspirin 75mg

Aspirin 1200mg

Lactose powder

Arm Description

Aspirin 75mg once daily for 7 days. Administered by mouth.

Asprin 600mg twice daily for 7 days. Administered by mouth.

Placebo for 7 days. Administered by mouth.

Outcomes

Primary Outcome Measures

Bronchoalveolar lavage IL-8 concentration

Secondary Outcome Measures

Alveolar inflammatory response biomarkers
Plasma inflammatory response biomarkers
Alveolar epithelial and endothelial function and injury biomarkers
Lipid inflammatory mediators

Full Information

First Posted
August 4, 2012
Last Updated
September 12, 2022
Sponsor
Belfast Health and Social Care Trust
Collaborators
The Intensive Care Society United Kingdom, Northern Ireland Clinical Trials Unit, Queen's University, Belfast
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1. Study Identification

Unique Protocol Identification Number
NCT01659307
Brief Title
The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury
Acronym
ARENA
Official Title
The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 9, 2022 (Actual)
Study Completion Date
September 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Belfast Health and Social Care Trust
Collaborators
The Intensive Care Society United Kingdom, Northern Ireland Clinical Trials Unit, Queen's University, Belfast

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
Keywords
Acute Lung Injury, Acute Respiratory Distress Syndrome, Aspirin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aspirin 75mg
Arm Type
Active Comparator
Arm Description
Aspirin 75mg once daily for 7 days. Administered by mouth.
Arm Title
Aspirin 1200mg
Arm Type
Active Comparator
Arm Description
Asprin 600mg twice daily for 7 days. Administered by mouth.
Arm Title
Lactose powder
Arm Type
Placebo Comparator
Arm Description
Placebo for 7 days. Administered by mouth.
Intervention Type
Drug
Intervention Name(s)
Aspirin 75mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lactose powder
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Aspirin 1200mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bronchoalveolar lavage IL-8 concentration
Time Frame
6 hrs after LPS inhalation
Secondary Outcome Measure Information:
Title
Alveolar inflammatory response biomarkers
Time Frame
6 hrs after LPS inhalation
Title
Plasma inflammatory response biomarkers
Time Frame
6 and 24 hrs after LPS inhalation
Title
Alveolar epithelial and endothelial function and injury biomarkers
Time Frame
6 hrs after LPS inhalation
Title
Lipid inflammatory mediators
Time Frame
6 and 24 hrs after LPS inhalation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danny McAuley
Organizational Affiliation
Queens University, Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Belfast Health and Social Care Trust
City
Belfast
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28082531
Citation
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.
Results Reference
derived
PubMed Identifier
26494395
Citation
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.
Results Reference
derived
PubMed Identifier
25486575
Citation
Curley GF, McAuley DF. Stem cells for respiratory failure. Curr Opin Crit Care. 2015 Feb;21(1):42-9. doi: 10.1097/MCC.0000000000000171.
Results Reference
derived

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

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