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Chronic obstructive pulmonary disease (COPD) is a common lower respiratory disease characterized by cough, difficulty breathing, and progressive and irreversible airflow limitation. As of 2020, 6.0% of Americans aged 45-64 years report COPD, increasing to 10.8% of those aged 65 years and older 1 . Since treatment is not curative, maintenance therapy is aimed at improving symptoms, decreasing exacerbations, and improving quality of life 2 . Maintenance pharmacotherapy recommendations are based on a patient’s symptoms and history of exacerbations, comprising primarily inhaled therapies, but also include oral therapies in certain populations (e.g., azithromycin (off-label) and roflumilast (labeled)). Inhaled therapies include long-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), and inhaled corticosteroids (ICS). Patients may begin needing only one agent but – with increased severity and symptoms – may progress to inhaled triple therapy with a LABA, LAMA, and ICS.
While multiple inhaler triple therapy (MITT) has been available in different forms since the approval of the first LAMA in 2004, single inhaler triple therapy (SITT) is a comparatively new addition with two fixed dose combination (FDC) LABA+LAMA+ICS inhalers approved since 2017. On September 18, 2017, the U.S. Food and Drug Administration (FDA) approved a once-daily, triple therapy LABA+LAMA+ICS inhaler, under the brand name Trelegy Ellipta, for the maintenance treatment of patients with COPD. Trelegy Ellipta is a combination of fluticasone furoate, umeclidinium, and vilanterol, (ICS+LAMA+LABA, respectively) delivered as a dry powder inhaler. On July 24, 2020, the FDA approved an additional once-daily triple therapy inhaler for the maintenance treatment of patients with COPD, under the brand name Breztri Aerosphere. Breztri Aerosphere combines formoterol fumarate, glycopyrrolate, and budesonide 3 , (LABA+LAMA+ICS, respectively) delivered as a metered dose inhaler. In contrast, MITT use is more heterogeneous and may consist of three separate single therapy inhalers for LABA, LAMA, and ICS products, or two separate inhalers containing a permutation of these products (e.g., a dual therapy FDC inhaler containing ICS+LABA products in addition to a single therapy inhaler containing a LAMA product).
The objective of this study is to describe the utilization patterns of single and multiple inhaler triple therapy among a population of triple therapy-naïve patients with COPD who had evidence of exacerbations despite dual inhaler therapy maintenance treatment in the Sentinel Distributed Database.