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

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 -agonist vilanterol (VI) in patients with chronic obstructive pulmonary disease...

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Bibliographic Details
Published in:International journal of chronic obstructive pulmonary disease Vol. 19; pp. 205 - 216
Main Authors: Beeh, Kai-Michael, Scheithe, Karl, Schmutzler, Heike, Krüger, Saskia
Format: Journal Article
Language:English
Published: New Zealand Dove Medical Press Limited 01-01-2024
Dove
Dove Medical Press
Subjects:
Care and treatment
cat score
Clinical trials
Corticosteroids
exacerbation
Lung diseases, Obstructive
lung function
Original Research
Patient compliance
Pharmaceutical industry
Product development
real-world evidence
Respiratory agents
treatment adherence
Germany
lung function
real-world evidence
treatment adherence
CAT score
exacerbation
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Summary: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 -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. 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 ), inhaler adherence, and safety. Nine hundred and six patients were included (age 66.6 years, 55.6% male, mean FEV 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 was improved by 93 mL (p < 0.0001). No new safety effects were observed. In usual care, treatment with odSITT resulted in significant and clinically relevant improvements of CAT score and FEV 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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ISSN:1178-2005
1176-9106
1178-2005
DOI:10.2147/COPD.S427770