Langdurige behandeling met inhalatiesteroïden heeft gunstig effect bij matig ernstige COPD*

OBJECTIVE : To determine if long-term treatment with inhaled steroids (ICS), both with and without long-acting β2-agonists (LABA) reduces inflammation and improves pulmonary function in COPD. DESIGN : Randomized placebo-controlled trial in two Dutch centres (http://clinicaltrials.gov/ct2/show/NCT00158847). METHODS : 114 steroid-naïve patients with moderate to severe COPD (smokers or ex-smokers) were treated double-blind with: (n = 26) fluticasone propionate 500 µg twice daily (bid) for 6 (n = 31) or 30 months, or with fluticasone 500 µg bid and salmeterol 50 µg bid (n = 28) for 30 months, or with placebo bid (n = 29). Primary outcomes were the cell counts of bronchial biopsies and sputum. Airway hyper-responsiveness was measured before randomisation and at 6 and 30 months; clinical outcomes were determined every 3 months. RESULTS : A total of 101 patients were > 70% adherent to therapy. After 6 months of fluticasone use the lymphocyte (CD3+, CD4+, and CD8+) and mast cell count in the airway wall decreased (only p <0.005) and the hyper-responsiveness improved (p <0.05) compared to the placebo. These effects were maintained after 30 months. Long-term treatment with fluticasone over 30 months reduced the number of mast cells and increased the percentage of intact epithelium in bronchial biopsies The neutrophil, macrophage and lymphocyte counts in sputum were reduced. These changes were accompanied by a slower deterioration in lung function (FEV1), and improvements in dyspnoea and quality of life. After discontinuation of fluticasone at 6 months CD3+, the mast cell and plasma cell count increased and clinical outcome worsened. Adding salmeterol to fluticasone improved FEV1-level. CONCLUSIONS : ICS treatment can decrease inflammation and reduce deterioration in lung function in steroid-naïve patients with moderate to severe COPD. Adding LABAs does not enhance these effects