Control of airway inflammation maintained at a lower steroid dose with 100/50 microg of fluticasone propionate/salmeterol

J Allergy Clin Immunol. 2006 Jul;118(1):44-52. doi: 10.1016/j.jaci.2006.03.043. Epub 2006 Jun 2.

Abstract

Background: Inhaled corticosteroids (ICSs) have been shown to reverse epithelial damage and decrease lamina reticularis thickness in patients with asthma.

Objective: This study investigated whether clinical asthma control and airway inflammation could be maintained after switching therapy from medium-dose fluticasone propionate (FP) to low-dose FP administered with the long-acting beta2-agonist (LABA) salmeterol.

Methods: Eighty-eight subjects (age, > or =18 years) who, during open-label screening, demonstrated improved asthma control after an increase from 100 microg of FP twice daily to 250 microg of FP twice daily were randomized to receive 100/50 microg of FP/salmeterol through a Diskus inhaler (GlaxoSmithKline, Research Triangle Park, NC) twice daily or continue 250 microg of FP twice daily through a Diskus inhaler for 24 weeks. Clinical outcomes were monitored, and bronchial biopsy specimens and bronchoalveolar lavage fluid were obtained before and after 24 weeks of treatment.

Results: There were no significant differences between treatments with respect to eosinophils in the bronchial mucosa and bronchoalveolar lavage fluid; mucosal mast cells, neutrophils, or CD3+, CD4+, CD8+, or CD25+ T lymphocytes; or concentration of mediators (GM-CSF, IL-8, and eosinophil cationic protein). The 2 treatments were not different with respect to lamina reticularis thickness. Consistent with the airway inflammatory measures, clinical and physiologic measures of asthma control were also similar.

Conclusion: This study demonstrates that control of asthma and airway inflammation is maintained over the 24-week treatment period when patients requiring a medium-dose ICS are switched to a lower-dose ICS with a LABA.

Clinical implications: A lower-dose ICS with a LABA is effective in controlling inflammation and providing clinical asthma control, confirming current guideline recommendations.

Publication types

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

MeSH terms

  • Adrenergic beta-Agonists / administration & dosage*
  • Adult
  • Albuterol / administration & dosage
  • Albuterol / adverse effects
  • Albuterol / analogs & derivatives*
  • Androstadienes / administration & dosage*
  • Androstadienes / adverse effects
  • Asthma / drug therapy*
  • Asthma / metabolism
  • Bronchoalveolar Lavage Fluid / chemistry
  • Female
  • Fluticasone
  • Humans
  • Immunohistochemistry
  • Male
  • Middle Aged
  • Prospective Studies
  • Salmeterol Xinafoate

Substances

  • Adrenergic beta-Agonists
  • Androstadienes
  • Salmeterol Xinafoate
  • Fluticasone
  • Albuterol