Abstract

The randomized controlled single hospital centre study assessed the efficacy of therapy with Berodual N (fenoterol / ipratropium) delivered by means of small spacers in patients with acute exacerbations of obstructive pulmonary diseases. Inclusion criteria were acute exacerbation of COPD or asthma, age 18–75 yrs, FEV1 30–60 %, no need for respiratory support. 61 patients with COPD or asthma (M : F = 37 : 24, mean age 59 ± 8 yrs; FEV1 — 40 ± 11 %, SpO2 = 94 ± 2 %) were randomized to Berodual N 2 inhalations via MDI (n = 31) or Berodual N 2 inhalations via spacer-MDI (n = 30). Therapy with Berodual N in both groups of patients led to statistically significant improvement in FEV1, FVC and IC, and to decrease in respiratory rate and dispnea. Therapy with Berodual N via spacer-MDI resulted in more significant improvement of FVC and IC (difference between groups after 0.5 and 1 h after inhalation: р < 0.05). Dyspnea score also improved more significantly in patients received Berodual N via spacer-MDI (difference between groups after 0.5 and 1 h after inhalation: р < 0.05). The incidence of adverse events was similar between the groups. Conclusion: in patients with acute exacerbations of obstructive pulmonary diseases therapy with Berodual N by means of small spacers and MDI is more effective in comparison with MDI only.

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