Outcomes of Once-Daily ICS/LABA/LAMA + PRN Respiratory Therapy Treatments in Hospitalized Patients With COPD Exacerbations

TRELEGY ELLIPTA is not prescribed as standard of care. Study participants will be consented prior to being prescribed TRELEGY ELLIPTA as part of this study.

Subjects will be given TRELEGY ELLIPTA once daily at the same time every day (± 2 hours). TRELEGY ELLIPTA will be initiated the morning of enrollment if feasible, or the morning following hospital enrollment otherwise. It will be administered as 1 inhalation by the orally inhaled route only.

When exacerbations of COPD that require hospitalization occur, short-acting bronchodilators (both beta agonists and anticholinergics) are routinely prescribed as part of a comprehensive regimen that includes supplemental oxygen, parenteral corticosteroids, antibiotics (usually), and if severe, non-invasive positive pressure ventilation. According to GOLD 2018 recommendations,2 long-acting bronchodilators are to be introduced as soon as possible prior to discharge from the hospital if not continued during hospitalization. However, the recommendation to use short-acting bronchodilators as a primary therapeutic inhalant is based on grade C level of evidence, suggesting a paucity of data to support that position. Primarily related to pharmacy-driven cost considerations, the exclusive use of short-acting bronchodilators has become the standard of care in treating hospitalized patients with COPD exacerbations, with the introduction of long-acting inhalants only upon discharge, by a number of institutions including Ben Taub Hospital in Houston (Nicola Hanania MD: personal communication), and throughout the Baylor Scott and White Healthcare System in Texas. This therapeutic substitution of short-acting for long-acting bronchodilators has been estimated to result in a cost savings of \~$400k at Baylor University Medical Center alone (personal communication: director of pharmacy services). Even so, few if any studies have evaluated the length of stay, in-hospital adverse events (nocturnal awakenings related to respiratory symptoms that occur beyond the window of pharmacologic efficacy of short-acting medications), respiratory therapy utilization or the potential impact upon re-hospitalizations with this paradigm shift of care. Sanford Hospital System in North Dakota recently published a study comparing a once daily long-acting combination with compared with a twice-daily combination and saw minimal cost savings and no real change in outcomes.3 This same system had previously studied substitution of twice daily beta agonist and once daily anticholinergic bronchodilators for combination short-acting bronchodilators and found improved outcomes and cost savings but reported their results in a non-peer reviewed journal in AARC Times, November 2011.

Results of an analysis of 60 patient charts randomly selected after hospitalization at Baylor University Medical Center for an exacerbation of underlying airways disease (greater than 90% with COPD) showed tremendous variation in practice patterns; with 30% of patients receiving short-acting beta-antagonists and muscarinic agonists (SABA/SAMA) only, 70% receiving long-acting beta-antagonists (LABA) with PRN SABA/SAMA, and only 42% receiving a long-acting muscarinic agonist (LAMA), despite practice guidelines encouraging the use of SABA/SAMA only (typically 4 times daily and as needed).