TY - JOUR T1 - Comparison of a dry powder inhaler (DPI) to a pressurized metered-dose inhaler (pMDI) formulation of extra fine beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB) in patients with COPD: The TRI-D study JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.congress-2020.3246 VL - 56 IS - suppl 64 SP - 3246 AU - Kai Michael Beeh AU - Piotr Kuna AU - Isabelle Viaud AU - Alessandro Guasconi AU - Massimo Corradi AU - George Georges Y1 - 2020/09/07 UR - http://erj.ersjournals.com/content/56/suppl_64/3246.abstract N2 - Introduction: A DPI formulation (NEXThaler®) of the extra fine BDP/FF/GB triple therapy has been developed as an alternative to pMDI to meet patients’ preference and to provide treatment options.Aims and Objectives: To demonstrate the non-inferiority of the DPI versus pMDI formulations of extra fine BDP/FF/GB on lung function.Methods: TRI-D was a, randomized, double-blind, double-dummy, active controlled, 3-way cross-over trial comparing 4 weeks of treatment with BDP/FF/GB 100/6/12.5 µg DPI and pMDI and BDP/FF 100/6 µg pMDI each delivered as 2 inhalations bid, separated by 2-week wash-outs in patients with stable, moderate-to-severe COPD. The co-primary efficacy endpoints were the change from baseline in FEV1 AUC0-12h normalised by time and in trough FEV1 at 24 hours on Day 28. Treatment-emergent adverse events (TEAEs) were collected.Results: 366 patients were randomized. Non-inferiority of BDP/FF/GB DPI vs pMDI was demonstrated for both co‑primary endpoints, with the lower limits of confidence interval of the adjusted mean differences falling above the non-inferiority threshold of -50 mL (-35 mL and -15 mL). Both DPI and pMDI triple therapies significantly improved FEV1 AUC0‑12h vs BDP/FF pMDI by 85 and 105 mL, respectively (p <0.001). TEAEs occurred in 15.2%, 18.7% and 15.4% of patients on BDP/FF/GB DPI, pMDI, and BDP/FF pMDI.Conclusion: DPI and pMDI formulations of extra fine BDP/FF/GB demonstrated similar efficacy and safety in patients with COPD supporting the new DPI formulation as a valid option for both patient and physician.FootnotesCite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 3246.This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only). ER -