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.
