TriOptimize II: The Use of Blood Eosinophil Count in the Care of Patients with COPD Prescribed Single Inhaler Therapy: A Real-World View from Germany

Introduction: TriOptimize is an ongoing multicenter observational trial, focusing on patients with COPD treated with single inhaler triple therapy (SITT) consisting of extrafine beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB). Here, we present data from an interim analysis of the first 1003 enrolled patients. Special attention is given to the alignment of SITT with recommendations of the 2018 GOLD Report as well as current discussions on the role of blood eosinophil count in the treatment decision for inhaled corticosteroids (ICS) in COPD in daily clinical practice.

Methods: This non-interventional study follows patients with COPD for 6 months and collects demographic, anamnestic and clinical data from the patientsʼ medical files. By the time of this interim analysis, 164 centers across Germany, specialized in respiratory care, have participated in the study. We report descriptive baseline characteristics on the first 1003 patients.

Results: The study population is 53.5% males, has an average age of 65.3 years, and an average BMI of 27.3, with 60.5% being former smokers and 39.5% current smokers with an average of 37.5 and 40.6 pack years respectively. The vast majority (98%) of patients are treated by office-based pulmonologists, and 2% treated at hospital ambulatory care clinics. Mean time from initial diagnosis to the first prescription of SITT was 7.1 years. At study entry, GOLD grade distribution was 5.3%, 38.7%, 20.9%, 35.1% for A, B, C, D, respectively. Blood eosinophil (EOS) levels were measured prior to initiating SITT in 21.6% of the cohort as part of clinical practice. Thirty percent (30%) of these patients had an EOS count of less than 100/µl, 28.6% between 101 and 200/µl, 23.5% between 201 and 300/µl and 18% above 300/µl.

Conclusion: These real-world results indicate that the majority of patients with COPD prescribed SITT with extrafine BDP/FF/GB by pulmonologists across Germany were GOLD grade B or D, reflecting a higher level of symptoms and a higher risk of exacerbation, respectively. EOS count did not seem to be used to guide SITT, probably due to the lack of consensus on cut-off values, and availability of published data showing efficacy of SITT across a wide range of EOS count in patients with COPD.