Acute Lung Injury Clinical Trial
Official title:
A Randomized, Placebo-controlled, Double-blind Study to Investigate the Effects of the Tyrosine Kinase Inhibitor Imatinib on Pulmonary Vascular Dysfunction in a Human Experimental Model of Acute Lung Injury
The study is a randomized, double-blind, placebo-controlled clinical study of imatinib (as
mesilate) in healthy subjects exposed inhaled lipopolysaccharide. During the study, eight
oral doses of imatinib, or placebo, will each be taken 12 hours apart, before subjects are
exposed to nebulized lipopolysaccharide (LPS). Four hours after LPS exposure, a
bronchoalveolar lavage (BAL) will be undertaken, and BAL fluid (BALF collected. Once study
assessments are completed, a follow-up visit will be conducted approximately 7 days after the
last dose of imatinib.
The primary objective of the study is to investigate the effect of imatinib on LPS-induced
pulmonary vascular dysfunction. The primary endpoints of this study are:
1. Change in the number of neutrophils in BALF 6 hours after the LPS challenge in subjects
exposed to imatinib compared with placebo.
2. Change in concentration of total protein in BALF 6 hours after the LPS challenge in
subjects exposed to imatinib compared with placebo
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