Basic therapy of uncontrolled and poorly controlled asthma: a comparison of Russian and foreign combined drugs
The aim. This study was aimed at assessment of clinical efficacy, tolerability and safety of two fixed combinations: Salticasone® Aeronativ (salmeterol + fluticasone) 25/125 μg (Russia) compared to Seretide® 25/125 3 μg (GlaxoSmithKline Pharmaceuticals C.A., Poland) in patients with uncontrolled and partly controlled asthma. Methods. This was a multicenter open randomized clinical trial involving two groups of patients at 1 : 1 ratio: patients treated with Salticasone® Aeronativ or Seretide®, two doses b.i.d. during 12 weeks. The primary endpoints were change in FEV1 from the baseline to the end of the study and proportion of patients achieving good asthma control to the end of the study according to ACT questionnaire. The secondary endpoints were change in the peak expiratory flow rate from the baseline to the end of the study; the average daily number of inhalations of short-acting beta-agonists as needed according to the patient’s dairy; time to the first exacerbation of asthma; asthma control level according to ACT questionnaire; change in asthma control according to ACQ questionnaire; change in quality of life according to AQLQ questionnaire; number of asthma exacerbations or seek for emergency care during the study. Results. One hundred and sixteen patients were included in the study, 58 patients in each group. The maximal length of the therapy was 98 days. Two groups did not differ significantly in all the primary and secondary end-points at baseline or in 12 weeks of therapy. The peak expiratory flow rate, asthma control level and quality of life improved equally in both the groups to the end of the study. Conclusion. The Russian combined aerosol inhaler Salticasone® Aeronativ (salmeterol + fluticasone), 25/125 μg is equally effective as Seretide® 25/125 μg (GlaxoSmithKline Pharmaceuticals C.A., Poland) in patients with uncontrolled and partly controlled asthma. Salticasone® Aeronativ has the similar safety profile and tolerability as Seretide®.