Triple therapy in COPD: new evidence with the extrafine fixed combination of beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide

Abstract

The goals of COPD therapy are to prevent and control symptoms, reduce the frequency and severity of exacerbations, and improve exercise tolerance. The triple combination therapy of inhaled corticosteroids (ICSs), long-acting beta₂ agonists (LABAs), and long-acting muscarinic antagonists (LAMAs) has become an option for maintenance treatment of COPD and as a “step-up” therapy from single or double combination treatments. There is evidence that triple combination ICS/LABA/LAMA with different inhalers improves lung function, symptoms, and health status and reduces exacerbations. A new triple fixed-dose combination of extrafine beclomethasone dipropionate (100 µg/puff)/formoterol fumarate (6 µg/puff)/glycopyrronium bromide (12.5 µg/puff) has been developed as a hydrofluoroalkane pressurized metered dose inhaler. Two large pivotal studies showed that this extrafine fixed ICS/LABA/LAMA triple combination is superior to fixed ICS/LABA combined therapy and also superior to the LAMA tiotropium in terms of lung function and exacerbation prevention in COPD patients at risk of exacerbation. This review considers the new information provided by these clinical trials of extrafine triple therapy and the implications for the clinical management of COPD patients.

Keywords:

• COPD
• inhaled triple therapy
• beclomethasone dipropionate
• formoterol fumarate and glycopyrronium bromide

Supplementary material

Table S1 TEAEs reported in ≥1% of patients with any treatment in safety population (integrated analysis)

Disclosure

DS reports grants and personal fees from Almirall, Astra-Zeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Glenmark, Johnson and Johnson, Merck, NAPP, Novartis, Pfizer, Takeda, Teva, Theravance, and Verona and personal fees from Genentech and Skyepharma. OSU has received industry-academic funding from Boehringer Ingelheim, Chiesi, Edmond Pharma, GlaxoSmithKline, Mundipharma International and has received consultancy or speaker fees from Astra Zeneca, Boehringer Ingelheim, Chiesi, Cipla, Edmond Pharma, GlaxoSmithKline, Napp, Novartis, Mundipharma International, Pearl Therapeutics, Roche, Sandoz, Takeda, UCB, Vectura and Zentiva. JV has received honoraria for consulting and presenting from AstraZeneca, Boehringer-Ingelheim, Chiesi, GlaxoSmithKline, and Novartis. AP reports grants, personal fees, non-financial support, and others from Chiesi, AstraZeneca, GlaxoSmith-Kline, Boehringer Ingelheim, Merck Sharp & Dohme, Pfizer, Takeda, Mundipharma and TEVA, personal fees and non-financial support from Menarini, Novartis and Zambon, and grants from Sanofi. MC received honoraria for consultancy from Chiesi Farmaceutici SpA.

MSp, SP, and MSc are full-time employees of Chiesi Farmaceutici SpA. The authors report no other conflicts of interest in this work.