GFF MDI for the improvement of lung function in COPD – A look at the PINNACLE-1 and PINNACLE-2 data and beyond

ABSTRACT

Introduction: Chronic obstructive pulmonary disease (COPD) is the third leading cause of death globally and incidence rates are continuing to rise. Long-acting bronchodilators are the foundation on which current pharmacological approaches to COPD management are built, with long-acting muscarinic antagonists (LAMAs) and long-acting β₂-agonists (LABAs) recommended across the spectrum of the disease continuum. Combining LAMAs and LABAs provides additional lung function improvements and relief of patient symptoms compared with either therapy alone. Several options for LAMA/LABA fixed-dose combinations (FDC) delivered via a single inhaler device are available; however, only recently has a LAMA/LABA FDC become available as a pressurized metered dose inhaler (MDI).

Areas covered: This article describes the rationale for the development of the LAMA/LABA FDC of glycopyrrolate and formoterol fumarate, formulated by Co-Suspension™ Delivery Technology and delivered by MDI (GFF MDI). The clinical trial program of GFF MDI, including the pivotal Phase III studies (PINNACLE-1 and PINNACLE-2) that supported regulatory approval, are reviewed, providing insights into interpretation and future directions for research.

Expert commentary: LAMA/LABA FDCs are already a crucial part of the COPD treatment paradigm, but additional data are needed in order to maximize their role as maintenance therapies in patients with COPD.

KEYWORDS:

• Bronchodilators
• COPD
• Co-Suspension™ Delivery Technology
• glycopyrrolate
• fixed-dose combination
• formoterol fumarate
• LABA
• LAMA
• metered dose inhaler

Declaration of interest

KF Rabe reports grants from Boehringer Ingelheim, the German Federal Ministry of Education and Research (BMBF), and Novartis. He has received personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Intermune, Novartis and Takeda. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Medical writing support was provided by Thomas Owens, PhD of Complete Medical Communications, Macclesfield, UK, which was funded by AstraZeneca, Cambridge, UK in accordance with Good Publication Practice (GPP3) guidelines [94].

Additional information

Funding

The PINNACLE studies were funded and supported by Pearl Therapeutics Inc., a member of the AstraZeneca Group. Co-Suspension is a trademark of the AstraZeneca group of companies.