Oral and inhaled p38 MAPK inhibitors: effects on inhaled LPS challenge in healthy subjects

Eur J Clin Pharmacol. 2015 Oct;71(10):1175-84. doi: 10.1007/s00228-015-1920-1. Epub 2015 Aug 13.

Abstract

Background: Inhaled LPS causes neutrophilic airway inflammation in healthy subjects. We compared the effects of p38 MAPK inhibitors and fluticasone propionate on the LPS response.

Methods: Three randomised, double-blind, placebo-controlled, single dose crossover studies were performed. Active treatments were the oral p38 MAPK inhibitor PH-797804 30 mg (study 1), PH-797804 30 mg and the inhaled p38 MAPK inhibitor PF-03715455 20 mg (study 2) and inhaled fluticasone propionate 500 μg (study 3). The primary endpoint was sputum neutrophil percentage.

Results: Sputum neutrophil percentage post-LPS challenge was significantly inhibited (15.1 and 15.3% reduction) by PH-797804 compared to placebo in studies 1 and 2 (p = 0.0096 and 0.0001, respectively), and by PF-03715455 (8.0% reduction, p = 0.031); fluticasone propionate had no effect. PH-797804 significantly inhibited the increase in inflammatory mediators (IL-6, MCP-1, MIP1β and CC16) in sputum supernatant, while PF-03715455 had no effect. PH-797804 and PF-03715455 both inhibited IL-6, MCP-1, MIP1β, CC16 and CRP levels in plasma, with PH-797804 having greater effects. Fluticasone propionate had no effect on sputum supernatant or plasma biomarkers.

Conclusions: PH-797804 had the greatest impact on neutrophilic airway inflammation. Oral administration of p38 MAPK inhibitors may optimise pulmonary anti-inflammatory effects.

Keywords: Induced sputum; LPS challenge; p38 MAPK inhibitors.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adult
  • Anti-Inflammatory Agents / pharmacology*
  • Azabicyclo Compounds / pharmacology*
  • Benzamides / pharmacology*
  • Bronchial Provocation Tests
  • Cross-Over Studies
  • Double-Blind Method
  • Female
  • Fluticasone / pharmacology*
  • Humans
  • Inflammation / metabolism
  • Inflammation Mediators / metabolism*
  • Lipopolysaccharides / pharmacology
  • Male
  • Methylurea Compounds / pharmacology*
  • Middle Aged
  • Neutrophils / metabolism
  • Pyridones / pharmacology*
  • Sputum / cytology
  • Young Adult
  • p38 Mitogen-Activated Protein Kinases / antagonists & inhibitors*

Substances

  • Anti-Inflammatory Agents
  • Azabicyclo Compounds
  • Benzamides
  • Inflammation Mediators
  • Lipopolysaccharides
  • Methylurea Compounds
  • PH 797804
  • Pyridones
  • N-(1-(3-chloro-4-hydroxyphenyl)-3-(1,1-dimethylethyl)-1H-pyrazol-5-yl)-N'-((2-((3-(2-((2-hydroxyethyl)thio)phenyl)-1,2,4-triazolo(4,3-a)pyridin-6-yl)thio)phenyl)methyl)-urea
  • Fluticasone
  • p38 Mitogen-Activated Protein Kinases