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

Geßner, Christian; Javan, S. Bahari; Hövelmann, R; Bogoevska, Valentina; Georges, George; Nudo, Elena; Criée, Carl-Peter

doi:10.2147/copd.s382405

Cited by 8 publications

(6 citation statements)

References 47 publications

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“… 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.…”

Section: Discussionsupporting

confidence: 68%

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

Beeh,

Scheithe,

Schmutzler

et al. 2024

COPD

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Purpose Real-life effectiveness data on once-daily single-inhaler triple therapy (odSITT) with the inhaled corticosteroid fluticasone furoate (FF), the long-acting muscarinic antagonist umeclidinium (UMEC), and the long-acting β 2 -agonist vilanterol (VI) in patients with chronic obstructive pulmonary disease (COPD) are important to complement evidence from well-controlled randomized clinical trials. Effectiveness of odSITT was quantified by assessing health status and symptoms in usual care. Patients and Methods ELLITHE was a single-country (Germany), multicenter, open-label, non-interventional effectiveness study between 2020 and 2022, evaluating the effect of treatment initiation with FF/UMEC/VI 100/62.5/25 µg once-daily via the ELLIPTA inhaler on improvements in clinical outcomes versus baseline in COPD patients. The primary endpoint was the change in the total COPD Assessment Test (CAT) score between baseline and month 12. Key secondary endpoints included change in CAT score over time, occurrence of exacerbations until month 12, changes in forced expiratory volume in one second (FEV 1 ), inhaler adherence, and safety. Results Nine hundred and six patients were included (age 66.6 years, 55.6% male, mean FEV 1 52.6% of predicted, mean CAT 21.5 units, 1.4 exacerbations/year pre-study). About 63.9% of patients were escalated from dual therapies, and 18% were switched from multiple-inhaler triple therapies. Reductions in CAT score at month 12 were statistically significant and above the threshold of clinical importance (−2.6 units; p < 0.0001). CAT score also improved at interim visits. CAT improvements were more pronounced in patients with high baseline scores and better inhaler adherence. Exacerbations during follow-up were rare (0.2 events/year) compared to pre-study (1.4 events/year). FEV 1 was improved by 93 mL (p < 0.0001). No new safety effects were observed. Conclusion In usual care, treatment with odSITT resulted in significant and clinically relevant improvements of CAT score and FEV 1 in COPD patients, regardless of the occurrence of exacerbations. These findings challenge the current guideline recommendations for SITT only in patients experiencing exacerbations.

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Section: Discussionsupporting

confidence: 68%

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

Beeh,

Scheithe,

Schmutzler

et al. 2024

COPD

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“…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).…”

Section: Discussionsupporting

confidence: 54%

“…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.…”

Section: Discussionsupporting

confidence: 54%

“…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.…”

Section: Discussionmentioning

confidence: 88%

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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

Richeldi,

Schino,

Bargagli

et al. 2024

COPD

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The TRITRIAL study assessed the effects of beclometasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) fixed combination in patients with chronic obstructive pulmonary disease (COPD) in a real-world setting, focusing on patient's experience and perspective through the use of patients reported outcomes. Patients and Methods: TRITRIAL was a multicenter, prospective, observational study conducted on patients with moderate-severe COPD treated with BDP/FF/G fixed therapy for 12 months. The main objective was to evaluate the impact of BDP/FF/G on health status through the COPD Assessment Test (CAT) score. Additional assessments included adherence and satisfaction, measured by the TAI-10/12 questionnaire and a specifically designed eight-item questionnaire, quality of life through the EQ-5D-5L test, sleep quality through the COPD and Asthma Sleep Impact Scale (CASIS), as well as safety and disease-related outcomes. Results: Data from 655 patients were analyzed in the study. The mean total CAT score significantly improved (from 22.8 at baseline to 18.1 at 6 months and 16.5 at 12 months; p < 0.0001), as well as all the eight CAT sub-items, which decreased on average by 0.5-0.9 points during the study. Adherence and usability of the inhaler also improved during the study, with a decrease in poor compliance (from 30.1% to 18.3%) and an increase in good compliance (from 51.8% to 58.3%) according to the TAI score. Patients also benefited from significantly improved quality of life (EQ Index from 0.70 to 0.80; EQ-5D VAS score from 55.1 to 63.1) and sleep quality (CASIS score from 41.1 to 31.8). Finally, patients reported a significant reduction in exacerbation during the past 12 months. Conclusion: TRITRIAL showed that the BDP/FF/G fixed combination is effective and safe in patients with moderate-severe COPD and poorly controlled disease, improving patients' HRQoL, sleep quality, adherence and inhaler usability and reducing COPD symptoms and the risk of exacerbation in a real-life setting.

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“…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.…”

Section: Discussionmentioning

confidence: 99%

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)

McCormack,

Paczkowski,

Gronroos

et al. 2024

Adv Ther

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Introduction Triple therapy (fluticasone furoate/umeclidinium/vilanterol; FF/UMEC/VI) has been shown to improve symptoms and reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. This real-world study compared exacerbation rates and healthcare resource utilization (HCRU) before and after initiation of FF/UMEC/VI in patients with COPD previously treated with inhaled corticosteroid (ICS)/long-acting β 2 -agonist (LABA). Methods This retrospective cohort study included commercial and Medicare Advantage with Part D administrative claims data from September 01, 2016, to March 31, 2020, of patients diagnosed with COPD. The index date was the date of the first FF/UMEC/VI claim (September 2017–March 2019). The 12 months prior to index (baseline) were used to assess patient characteristics and outcomes; the 12 months following index (follow-up) were used to assess study outcomes. All patients had ≥ 30 consecutive days’ supply of any ICS/LABA dual therapy during the 12 months prior to FF/UMEC/VI initiation. Subgroup analyses included patients with ≥ 30 consecutive days’ supply of budesonide/formoterol (BUD/FORM) during baseline. Analyses of patients with ≥ 1 COPD exacerbation during baseline were reported as well. Results The overall population included 1449 patients (mean age 70.75 years; 54.18% female), of whom 540 were patients in the BUD/FORM subgroup. Significantly fewer patients experienced any exacerbation during follow-up versus baseline (overall population 53.49% vs 62.59%; p < 0.001; BUD/FORM subgroup 55.00% vs 62.41%; p = 0.004). Effects on exacerbation reduction were more pronounced among patients with ≥ 1 exacerbation during baseline. Lower COPD-related HCRU was observed during the follow-up compared with baseline for both the overall population and the BUD/FORM subgroup. Conclusion Patients with COPD treated with ICS/LABA during baseline, including patients specifically treated with BUD/FORM and those with a history of ≥ 1 exacerbation, had fewer COPD exacerbations and lower COPD-related HCRU after initiating FF/UMEC/VI. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-023-02776-8.

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

Cited by 8 publications

References 47 publications

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

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

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

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)

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