Effectiveness of Extrafine Single Inhaler Triple Therapy in Chronic Obstructive Pulmonary Disease (COPD) in Germany – The TriOptimize Study

Abstract

Purpose Real-word evidence on the effectiveness of switching from dual therapies or triple therapies (multiple inhalers) to extrafine single-inhaler triple therapy (efSITT), which consists of the inhaled corticosteroid (ICS) beclomethasone, the long-acting β 2 -agonist (LABA) formoterol and the long-acting muscarinic antagonist (LAMA) glycopyrronium, in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) is limited. The impact of switching to efSITT on health-related quality of life (HRQoL), COPD specific symptoms, lung function and treatment adherence were assessed in routine clinical care. Patients and Methods Patients were recruited at 148 sites in Germany between 2017 and 2020 in this multicenter, non-interventional observational study. Demographics, clinical data and treatment history were collected at baseline. HRQoL (measured by COPD Assessment Test [CAT]), lung function and adherence (measured by Test of Adherence to Inhalers [TAI]) were assessed at baseline and after six months. Descriptive analyses were conducted by prior treatment and GOLD groups as well as for the overall population. Results 55.1% of the 2623 included patients were male. Mean age was 65.8 years. 57.5% of the patients were previously treated with ICS+LABA+LAMA (multiple inhalers), 23.9% with ICS/LABA (single or two inhalers) and 18.6% with LAMA/LABA (single or two inhalers). After six months, largest mean improvements in the total CAT score were observed in the ICS/LABA (−3.9) and LAMA/LABA (−3.9) prior treatment groups as well as in patients in GOLD group B (−2.9). In the overall population, the CAT items for cough, phlegm, and dyspnea decreased on average by −0.4 points each. After six months, FEV 1 increased by 2.0 percentage points in relation to predicted values. The percentages of measured sRtot and RV of predicted values decreased by 24.5 and 4.4 percentage points, respectively. The percentage of patients with good adherence increased from 67.8% to 76.5%. Conclusion Treatment switch to efSITT resulted in an improvement of HRQoL, COPD specific symptoms, lung function parameters and adherence under real-world conditions.

Real-World Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol Once-Daily Single-Inhaler Triple Therapy for Symptomatic COPD: The ELLITHE Non-Interventional Trial

“… 13 Importantly, ELLITHE study results on CAT score are in line with recent findings in a non-interventional study with a different, twice-daily SITT (beclomethasone/formoterol/glycopyrronium via pressurized metered dose inhaler). 45 In this study, improvements in CAT score of 2.7 units were observed, with similar overall baseline CAT scores (21.5 units), although the observation period of 6 months was considerably shorter than in ELLITHE.…”

TRITRIAL: The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease in an Italian Context of Real Life

“…A limitation of this questionnaire is the lack, so far, of an MCID in the literature; however, it is now a wellestablished tool in the real-life contest, and it is being more and more used to assess the level of adherence at different visits. 22,23,26 Moreover, the improvement in treatment adherence with extrafine triple therapy has been reported in other observational studies using the TAI score. 22,26,27 On average, the level of adherence reported in this study was already acceptable at the first visit (average score of 46.3).…”

“…22,23,26 Moreover, the improvement in treatment adherence with extrafine triple therapy has been reported in other observational studies using the TAI score. 22,26,27 On average, the level of adherence reported in this study was already acceptable at the first visit (average score of 46.3). This is probably explained by the fact that patients included in the study represent a cohort that has already started therapy with BDP/FF/G.…”

“…The TriOptimize study showed that switching from dual/triple therapies with multiple inhalers to extra-fine single-inhaler triple therapy was associated with an improvement of HRQoL, COPD-specific symptoms, lung function parameters and adherence, measured with TAI-12 among German patients with moderate-severe COPD and poor symptom control. 22 Similarly, the Austrian real-world study TRICOP reported an improvement in lung function, symptom control and a significant reduction in exacerbations in patients with COPD treated with BDP/FF/G over 52 weeks. 23 One peculiar feature that sets TRITRIAL apart from previous observational studies is the patient-centric nature and the specific focus on capturing patients' perceptions and points of view on the everyday use of the BDP/FF/G fixed combination.…”

Outcomes of Patients with COPD Treated with ICS/LABA Before and After Initiation of Single-Inhaler Triple Therapy with Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)

“…Real-world evidence on the occurrence of COPD exacerbations before and after initiation of SITT are lacking. A recent observational, noninterventional study in Germany demonstrated that patients with moderate-to-severe COPD with at least one exacerbation in the previous 12 months before switching to SITT (ICS/LAMA/LABA) from ICS/LABA (single or two inhalers) as part of routine clinical care experienced an improvement in health-related quality of life, lung function, and treatment adherence [ 13 ]. To our knowledge, there were no real-world studies evaluating the effectiveness of switching from dual therapy to SITT on reducing exacerbation frequency in US populations prior to the current study.…”