TriOptimize I: Real World Evidence with extrafine single inhaler Triple Therapy in COPD

Background and Study Design Recently, randomized, controlled clinical trials demonstrated beneficial therapeutic effects of single inhaler triple therapy (SITT) consisting of extrafine beclomethasone dipropionate (BDP), formoterol fumarate (FF) and glycopyrronium (G) in the treatment of patients with severe to very severe COPD at risk of exacerbations. SITT with BDP/FF/G significantly reduced exacerbation rates compared to a therapy with a LAMA, an ICS/LABA combination or a LAMA/LABA combination. TriOptimize is the first prospective observational non-interventional study, aiming to evaluate the changes in health-related quality of life as measured by the COPD assessment Test (CAT) in patients with moderate-severe COPD and a history of ≥ 1 exacerbation in the previous 12 months, after treatment with extrafine BDP/FF/G therapy for 6 months in a real-world setting in Germany. Here, we present the baseline characteristics of the first 1003 enrolled subjects.

Results At study entry, the average age was 65.3 years, the BMI was 27.3 and 53.6% were males. 60.5% of patients were former smokers (average number of pack years: 37.5) and 39.5% current smokers (average number of pack years: 40.6). The average time of illness was 7.1 years. At time of first diagnosis, 44% of patients were classified as GOLD stage 3 or 4. This proportion has increased to 60% at the time of enrollment in the study. Average CAT score at study entry was 21.3 and GOLD grade distribution was 5.3%, 38.7%, 20.9% 35.1% for A, B, C and D respectively. Previous treatment consisted predominantly of multi-inhaler triple therapy (MITT; 44%) or ICS/LABA fixed dose combination (21.4%). A total of 80.9% of patients receiving ICS/LABA treatment were prescribed a twice daily posology. Overall 41% of patients were using at least 2 different inhalers and approximately 25% of patients self-reported concomitant asthma.

Summary The baseline characteristics of the first 1003 patients enrolled in the ongoing TriOptimize study show a patient population whose COPD is poorly controlled despite their current treatment. The progressive decline in lung function in this patient population prompts an evaluation of their disease management strategy including treatment adherence as well as intensity starting from the onset of diagnosis.