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

Phase 2

Completed

• Conditions: Acute Lung Injury
• Interventions: Drug: Aspirin 75mg; Drug: Aspirin 1200mg; Drug: Lactose powder

• Registration Number: NCT01659307
• Lead Sponsor: Belfast Health and Social Care Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-04
• Study First Submitted QC: 2012-08-04
• Study First Posted: 2012-08-07
• Study Start: 2012-09
• Status Verified: 2022-09
• Primary Completion: 2022-09-09
• Study Completion: 2022-09-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin 75mg	Aspirin 75mg	Aspirin 75mg once daily for 7 days. Administered by mouth.
Aspirin 1200mg	Aspirin 1200mg	Asprin 600mg twice daily for 7 days. Administered by mouth.
Lactose powder	Lactose powder	Placebo for 7 days. Administered by mouth.

Primary Outcome Measures

Name	Time	Method
Bronchoalveolar lavage IL-8 concentration	6 hrs after LPS inhalation

Secondary Outcome Measures

Name	Time	Method
Plasma inflammatory response biomarkers	6 and 24 hrs after LPS inhalation
Alveolar inflammatory response biomarkers	6 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

Trial Locations

Locations (1)

Belfast Health and Social Care Trust; 🇬🇧 Belfast, United Kingdom