Abstract
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.
Footnotes
Cite 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).
- Copyright ©the authors 2020