Clinical Trials Logo
  1. Home
  2. Acute Lung Injury
  3. NCT01659307
  4. Details
NCT01659307 Clinical Trial

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

Acute Lung Injury Clinical Trial

— ARENA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01659307
Other study ID # 11127DMcA-AS
Secondary ID 2012-001589-13
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2012
Est. completion date September 9, 2022

Study information
Verified date September 2022
Source Belfast Health and Social Care Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date September 9, 2022
Est. primary completion date September 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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.
• 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.

Locations
Country Name City State
United Kingdom Belfast Health and Social Care Trust Belfast

Sponsors (4)
Lead Sponsor Collaborator
Belfast Health and Social Care Trust Northern Ireland Clinical Trials Unit, Queen's University, Belfast, The Intensive Care Society United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bronchoalveolar lavage IL-8 concentration 6 hrs after LPS inhalation
Secondary Alveolar inflammatory response biomarkers 6 hrs after LPS inhalation
Secondary Plasma inflammatory response biomarkers 6 and 24 hrs after LPS inhalation
Secondary Alveolar epithelial and endothelial function and injury biomarkers 6 hrs after LPS inhalation
Secondary Lipid inflammatory mediators 6 and 24 hrs after LPS inhalation
See also
  Status Clinical Trial Phase
Recruiting NCT03937947 - Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
Completed NCT04247477 - Comparison of Different PEEP Titration Strategies Using Electrical Impedance Tomography in Patients With ARDS N/A
Completed NCT03315702 - Effect of Mechanical Ventilation on Plasma Concentration Level of R-spondin Proteins
Not yet recruiting NCT02693912 - Changes in Alveolar Macrophage Function During Acute Lung Injury N/A
Unknown status NCT01186874 - Epidemiology Research on Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) in Adult ICU in Shanghai N/A
Completed NCT01552070 - Recruitment on Extravascular Lung Water in Acute Respiratory Distress Syndrome (ARDS) Phase 2
Withdrawn NCT00961168 - Work of Breathing and Mechanical Ventilation in Acute Lung Injury N/A
Recruiting NCT00759590 - Comparison of Two Methods to Estimate the Lung Recruitment N/A
Completed NCT02475694 - Acute Lung Injury After Cardiac Surgery: Pathogenesis N/A
Completed NCT00736892 - Incidence of Acute Lung Injury: The Alien Study
Completed NCT00825357 - Biological Markers to Identify Early Sepsis and Acute Lung Injury N/A
Terminated NCT00263146 - Recruitment Maneuvers in ARDS: Effects on Respiratory Function and Inflammatory Markers. N/A
Completed NCT00188058 - Comparison of 2 Strategies of Adjustment of Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome N/A
Completed NCT00234767 - Study of the Economics of Pulmonary Artery Catheter Use in Patients With Acute Respiratory Distress Syndrome (ARDS) Phase 3
Recruiting NCT02598648 - Role and Molecular Mechanism of Farnesoid X Receptor(FXR) and RIPK3 in the Formation of Acute Respiratory Distress Syndrome in Neonates N/A
Recruiting NCT02948530 - Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods (Lungbarometry)
Completed NCT01532024 - Exploratory Clinical Study of Neutrophil Activation Probe (NAP) for Optical Molecular Imaging in Human Lungs Early Phase 1
Recruiting NCT01992237 - Measuring Energy Expenditure in ECMO (Extracorporeal Membrane Oxygenation) Patients N/A
Completed NCT01486342 - PET Imaging in Patients at Risk for Acute Lung Injury N/A
Withdrawn NCT01195428 - Simvastatin Effect on the Incidence of Acute Lung Injury/Adult Respiratory Distress Syndrome (ALI/ARDS) N/A