Results of an open-label, randomized, multicenter, comparative study of clinical efficacy and safety of Pulmibud drug and Pulmicort drug in patients with partially controlled and uncontrolled persistent bronchial asthma

A prospective, open-label, randomized, multicenter, comparative, phase III study was performed for the purpose of evaluating non-inferiority and safety of «Pulmibud» budesonide inhalation suspension (AO «AKRIKHIN», Russia) in comparison with Pulmicort reference product (AstraZeneka) in patients with partially controlled and uncontrolled persistent bronchial asthma. Materials and methods. The study included 160 patients randomized into two equal groups (n=80): «Pulmibud» group and Pulmicort group. The primary efficacy endpoint was the dynamics of the mean incremental FEV1 on the 84th day of therapy compared to the baseline. The margin of non-inferiority amounted to 200 ml, which corresponds to the upper range of clinically significant difference for adult patients with asthma. Results. Similar changes in the primary and secondary endpoints have been achieved in all groups: mean increase of FEV1 was 111.4±376.1 ml in the «Pulmibud» group and 122.1±372.4 ml in the Pulmicort group (difference —10.7±109.6 ml; p=0.9315), which confirmed the non-inferiority hypothesis. The safety profile was also comparable: 50 adverse events (31.25% of patients) in the «Pulmibud» group and 52 (30.00%) in the Pulmicort group. Conclusion. The study results demonstrate the therapeutic equivalence of «Pulmibud» generic drug and original Pulmicort in adult patients with persistent bronchial asthma.