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 β₂-agonists (ICS/LABA) in patients with asthma with combinedcold and osmotic airway hyperresponsiveness. The aim of the study was to compare the effectiveness of anti-inflammatory therapy with combinations of beclometh-asone 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^st group (n=22) took the therapy with a combination of beclomethasone dipro-pionate/formoterol fumarate; the 2nd group (n=15) had the therapy with a combination of budesonide/formote-rol. 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 (1st visit), after 6 weeks (2nd visit) and 12 weeks (3^rd visit). At the 1^st and 3^rd visits, the collection and cyto-logical 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 FEV₁ (94.0±3.7 and 98.0±5.0%, p>0.05). By the end of treatment the patients of the 1st 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 (FEV₁ 101.9±3.3; p=0.009) and small (FEF_25-75 75.0±4.5%; p=0.011) bronchi, and a decrease in airway response to the inhalation of broncho-dilator (the growth of FEV1 decreased from 16.1±3.5 till 8.0±1.74%, p=0.01). In patients of the 2^nd group at the time of the 3rd visit, the level of asthma control was 19.0±1.2 points (p=0.08), FEV₁ was 96.9±4.78% (p=0.67), MEF_25-75 was 76.5±9.53% (p=0.84), the growth of FEV₁ under bronchodilator did not significantly change (7.2±1.4% at the 1^st visit and 6.1±2.6% at the 3rd visit; p=0.84). In the study of cytological smears of IS in patients of 1^st 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^nd 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 dipro-pionate/formoterol fumarate leads to an improvement in clinical and functional parameters and a decrease in the number of eosinophils in induced sputum.

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