COMPARATIVE EVALUATION OF THE EFFECTIVENESS OF ANTI-INFLAMMATORY THERAPY OF BRONCHIAL ASTHMA WITH COMBINED INHALED MEDICATIONS IN PATIENTS WITH COLD AND OSMOTIC AIRWAY HYPERRESPONSIVENESS
There is no information on relief of clinical symptoms, achievement of criteria for disease control and regulation of inflammatory patterns of the bronchi in the application of the strategy of long-term anti-inflammatory therapy with various fixed combinations of inhaled glucocorticosteroids with long-acting β<sub>2</sub>-agonists (ICS/LABA) in patients with asthma with combined cold and osmotic airway hyperresponsiveness. The aim of the study was to compare the effectiveness of anti-inflammatory therapy with combinations of beclomethasone dipropionate/formoterol fumarate and budesonide/formoterol in asthma patients with combined airway hyperresponsiveness to cold and osmotic triggers. The clinical study involved 37 patients with asthma of a mixed form, and of a persistent course with documented combined cold and osmotic airway hyperresponsiveness. After randomization into groups, two fixed combination drugs ICS/LABA were used for treatment for 12 weeks: the 1<sup>st</sup> group (n=22) took the therapy with a combination of beclomethasone dipropionate/formoterol fumarate; the 2<sup>nd</sup> group (n=15) had the therapy with a combination of budesonide/formoterol. The control of asthma using Asthma Control Test questionnaire (ACT), a lung function and a reaction of airways to the inhalation of β2-agonist were assessed initially (1<sup>st</sup> visit), after 6 weeks (2<sup>nd</sup> visit) and 12 weeks (3<sup>rd</sup> visit). At the 1<sup>st</sup> and 3<sup>rd</sup> visits, the collection and cytological examination of induced sputum (IS) were carried out. At the time of randomization in groups, patients in groups 1 and 2 had no differences in ACT (17.1±1.1 and 16.5±1.6 points, p>0.05) and FEV<sub>1</sub> (94.0±3.7 and 98.0±5.0%, p>0.05). By the end of treatment the patients of the 1<sup>st</sup> group had the achievement of a good level of asthma control (an average of 21.7±0.6 points, p=0.0001), improvement of airway conductivity at the level of large (FEV<sub>1</sub> 101.9±3.3; p=0.009) and small (FEF<sub>25-75 </sub>75.0±4.5%; p=0.011) bronchi, and a decrease in airway response to the inhalation of bronchodilator (the growth of FEV<sub>1</sub> decreased from 16.1±3.5 till 8.0±1.74%, p=0.01). In patients of the 2<sup>nd</sup> group at the time of the 3<sup>rd</sup> visit, the level of asthma control was 19.0±1.2 points (p=0.08), FEV<sub>1</sub> was 96.9±4.78% (p=0.67), MEF<sub>25-75</sub> was 76.5±9.53% (p=0.84), the growth of FEV<sub>1 </sub>under bronchodilator did not significantly change (7.2±1.4% at the 1<sup>st</sup> visit and 6.1±2.6% at the 3<sup>rd</sup> visit; p=0.84). In the study of cytological smears of IS in patients of 1<sup>st</sup> group, there was a significant decrease in the number of eosinophils (from 12.7±2.5 to 3.3±0.64%; p=0.0015) and an increase in the number of neutrophils (from 42.3±3.0 to 60.4±1.3%; p=0.00004). The number of neutrophils in IS in the patients the 2<sup>nd</sup> group by the end of the observation decreased (from 55.8±5.0 to 42.8±3.5%; p=0.021), the number of eosinophils remained at the same level (9.2±2.95 and 6.5±2.53%; p=0.37). Thus, a 12-week therapy with a combination of beclomethasone dipropionate/formoterol fumarate leads to an improvement in clinical and functional parameters and a decrease in the number of eosinophils in induced sputum.