NCT01659307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

10 years

First QC Date

August 4, 2012

Last Update Submit

September 12, 2022

Conditions

Acute Lung Injury

Keywords

Acute Lung InjuryAcute Respiratory Distress SyndromeAspirin

Outcome Measures

Primary Outcomes (1)

  • Bronchoalveolar lavage IL-8 concentration

    6 hrs after LPS inhalation

Secondary Outcomes (4)

  • Alveolar inflammatory response biomarkers

    6 hrs after LPS inhalation

  • Plasma inflammatory response biomarkers

    6 and 24 hrs after LPS inhalation

  • Alveolar epithelial and endothelial function and injury biomarkers

    6 hrs after LPS inhalation

  • Lipid inflammatory mediators

    6 and 24 hrs after LPS inhalation

Study Arms (3)

Aspirin 75mg

ACTIVE COMPARATOR

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

Drug: Aspirin 75mg

Aspirin 1200mg

ACTIVE COMPARATOR

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

Drug: Aspirin 1200mg

Lactose powder

PLACEBO COMPARATOR

Placebo for 7 days. Administered by mouth.

Drug: Lactose powder

Interventions

Aspirin 75mgDRUG

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.

Aspirin 75mg
Lactose powderDRUG

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.

Lactose powder
Aspirin 1200mgDRUG

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.

Aspirin 1200mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Belfast Health and Social Care Trust

Belfast, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 28082531DERIVED

  • 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.

    PMID: 26494395DERIVED

  • Curley GF, McAuley DF. Stem cells for respiratory failure. Curr Opin Crit Care. 2015 Feb;21(1):42-9. doi: 10.1097/MCC.0000000000000171.

    PMID: 25486575DERIVED

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Distress Syndrome

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Danny McAuley

    Queens University, Belfast

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Intensive care Medicine

Study Record Dates

First Submitted

August 4, 2012

First Posted

August 7, 2012

Study Start

September 1, 2012

Primary Completion

September 9, 2022

Study Completion

September 9, 2022

Last Updated

September 13, 2022

Record last verified: 2022-09

Locations

GB(1)