The double bronchodilation era: new capabilities in a new drug delivery device

Abstract

A literature review presents the efficacy and safety of the new glycopyrronium bromide/formoterol fumarate (GP/FF) combination in the treatment of patients with chronic obstructive pulmonary disease according to the PINNACLE 1, 2, 3, 4 studies. There are 4 fixed LAMA/LABA combinations which used in world practice, as well as in Russia: vilanterol + umeclidinium bromide, glycopyrronium bromide + indacaterol, olodaterol + tiotropium bromide and aclidinium bromide + formoterol. The GP/FF combination also approved in Russia, is currently present in Global Initiative for Chronic Obstructive Lung Disease (GOLD). A new method of co-suspension delivery via the Aerosphere inhaler has been developed for this combination. The efficacy and safety in GP/FF MDI compared to its monocomponents and tiotropium bromide were assessed in phase III clinical trials PINNACLE 1, 2, 3, 4. The GP/FF combination showed an improvement in the morning and after 2 hours parameters of FEV1 compared to monocomponents and placebo. Data from PINNACLE studies showed an improvement in the quality of life associated with a decrease in compared with the baseline level of the overall score on the scale of the St. George’s Hospital Respiratory Questionnaire (SGRQ) in 24 weeks against those taking GP/FF in contrast to monocomponents and placebo. The use of GP/FF showed a significant reduction in theuse of salbutamol compared with placebo. A pooled analysis of PINNACLE 1, 2, 4 demonstrated that GP/FF improved lung functionand reduced the risk of COPD exacerbations compared with monocomponents and placebo. According to the results of the analysis, there was also no increase in the number of the most frequently recorded side effects.