TY - JOUR T1 - Integrated analyses of phase II safety data support the safety of glycopyrrolate-formoterol fumarate (GFF) MDI (PT003) and glycopyrrolate (GP) MDI (PT001) in COPD JF - European Respiratory Journal JO - Eur Respir J VL - 42 IS - Suppl 57 SP - P4141 AU - Roberto Rodriguez-Roisin AU - Leonardo Fabbri AU - Chadwick Orevillo AU - Carlos Fernandez AU - Patrick Darken AU - Earl St. Rose AU - Tracy Fischer AU - Christine Kollar AU - Colin Reisner Y1 - 2013/09/01 UR - http://erj.ersjournals.com/content/42/Suppl_57/P4141.abstract N2 - RationaleIn order to evaluate the overall safety profile and support dose selection of GFF MDI and GP MDI for Phase III studies, pooled analyses of safety data from 6 chronic-dosing studies were done.MethodsPooled analyses included the Safety Population from 6 randomized, double-blind, chronic dosing studies in patients with COPD. All studies had 7-day treatment durations except two (14-days). The studies included GFF MDI, GP MDI, fomoterol fumarate (FF) MDI, tiotropium DPI, FF DPI, ipratropium MDI and placebo treatments.ResultsThe analyses included a total of 942 patients. In GFF MDI groups, 15-42% of patients experienced one or more adverse effects (AE) (highest incidence with GFF MDI 72/9.6 µg). The incidence was 10-26% in GP MDI groups, 19% for placebo, 31% for ipratropium MDI, 30% for tiotropium DPI, 25-27% in FF MDI groups and 30% for FF DPI (Figure 1). The most frequently reported AEs were dry mouth, headache and tremor. There were 27 serious AEs and 2 deaths; deaths were deemed unrelated to study treatment by the investigator. There were no clinically relevant differences between groups on vital signs, laboratory values or ECGs.ConclusionThese data support the safety and progression of GFF MDI 18/9.6 µg and GP MDI 18 µg administered twice daily into Phase III trials in patients with COPD.Figure 1. Percentage of Patients with 1 or more AE. ER -