Skip to main content
OpenTrials
Completed

NCT Number: NCT01659307

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Lung Injury Lung Diseases Lung Injury Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Belfast Health and Social Care Trust

Belfast, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin 75mg

Drug

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.

Lactose powder

Drug

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.

Aspirin 1200mg

Drug

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 outcomes

  1. Bronchoalveolar lavage IL-8 concentration

    Time frame: 6 hrs after LPS inhalation

Secondary outcomes

  1. Alveolar inflammatory response biomarkers

    Time frame: 6 hrs after LPS inhalation

  2. Plasma inflammatory response biomarkers

    Time frame: 6 and 24 hrs after LPS inhalation

  3. Alveolar epithelial and endothelial function and injury biomarkers

    Time frame: 6 hrs after LPS inhalation

  4. Lipid inflammatory mediators

    Time frame: 6 and 24 hrs after LPS inhalation

Sponsors and collaborators

Lead sponsor

Belfast Health and Social Care Trust

Other

Collaborators

  • Northern Ireland Clinical Trials Unit
  • Queen's University, Belfast
  • The Intensive Care Society United Kingdom

Registry information

Acronym: ARENA

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Aug 7, 2012
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.