Validation of the human ozone challenge model as a tool for assessing anti-inflammatory drugs in early development

J Clin Pharmacol. 2005 May;45(5):498-503. doi: 10.1177/0091270004273527.

Abstract

This study aimed to test the utility of the ozone challenge model for profiling novel compounds designed to reduce airway inflammation. The authors used a randomized, double-dummy, double-blind, placebo-controlled 3-period crossover design alternating single orally inhaled doses of fluticasone propionate (inhaled corticosteroids, 2 mg), oral prednisolone (oral corticosteroids, 50 mg), or matched placebo. At a 2-week interval, 18 healthy ozone responders (>10% increase in sputum neutrophils) underwent a 3-hour ozone (250 ppb)/intermittent exercise challenge starting 1 hour after drug treatment. Airway inflammation was assessed at 2 hours (breath condensate) and 3 hours (induced sputum) after ozone challenge. Compared to placebo, pretreatment with inhaled corticosteroids or oral corticosteroids resulted in a significant reduction (mean [95% confidence interval]) of sputum neutrophils by 62% (35%, 77%) and 64% (39%, 79%) and of sputum supernatant myeloperoxidase by 55% (41%, 66%) and 42% (25%, 56%), respectively. The authors conclude that an optimized ozone challenge model (including ozone responders and ensuring adequate drug levels during exposure) may be useful for testing novel anti-inflammatory compounds in early development.

Publication types

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

MeSH terms

  • Administration, Inhalation
  • Administration, Oral
  • Adult
  • Androstadienes / administration & dosage
  • Androstadienes / pharmacology
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / pharmacology
  • Bronchial Provocation Tests / methods*
  • Cross-Over Studies
  • Double-Blind Method
  • Drug Evaluation / methods*
  • Female
  • Fluticasone
  • Humans
  • Male
  • Models, Biological
  • Ozone*
  • Prednisolone / administration & dosage
  • Prednisolone / pharmacology
  • Respiratory Function Tests
  • Sputum / cytology
  • Sputum / metabolism

Substances

  • Androstadienes
  • Anti-Inflammatory Agents
  • Ozone
  • Prednisolone
  • Fluticasone