Effects of fenspirid on some parameters of mucosal immunity in patients with early-stage chronic obstructive pulmonary disease

Abstract

The aim of this study was to evaluate influence of fenspirid on clinical and immune parameters of early-stage COPD. Workers (all were males) from a large machine-building enterprise of Chelyabinsk having stable COPD stage I or II participated in the study. They were randomized in 2 groups: 30 patients received fenspirid 80 mg b.i.d. and 30 patients received placebo (calcium gluconate) b.i.d. during 6 months. We assessed the patients' complaints, severity of cough and dyspnea, sputum volume, lung function parameters, measured saliva concentrations of final NO metabolites using the Griess reaction, lactoferrin, IL-8, and mucins using immune enzyme analysis. To the end of the treatment period, FEV₁ significantly increased in the fenspirid group (from 57.42 ± 1.66 % до 61.93 ± 2.59 %; p < 0.05) whereas it did not change significantly in the placebo group. Clinical improvement (reduction in cough, sputum volume, dyspnea, wheeze) was noted in 26 patients (86.6 %) and 16 patients (53.3 %), respectively. Lactoferrin concentration decreased from 486.01 ± 60.59 to 96.40 ± 10.17 μg ml^–1 (p < 0.05), IL-8 decreased from 111.7 ± 16.68 tо 41.90 ± 6.60 μg ml^–1 (p < 0.05), mucin protein concentration increased from 110.8 ± 13.28 tо 298.4 ± 33.14 μg ml^–1 (p < 0.05), NO_x decreased from 11.21 ± 0.91 tо 6.15 ± 2.06 μmol L^–1 (p < 0.05). These parameters in the placebo group changed nonsignificantly. Exacerbations of COPD occurred in 6 patients (20 %) of fenspirid group and 10 patients (33.3 %) of the placebo group during the study period. Tolerance of the drug was generally good. Thus, fenspirid has significant antiinflammatory effect, improves clinical signs of COPD and FEV₁. The results suggest that fenspirid could be useful in early-stage COPD patients.