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Observational Study
. 2024 Jan-Dec:18:17534666241263439.
doi: 10.1177/17534666241263439.

Extrafine single inhaler triple therapy effectiveness in COPD patients previously treated with multiple-inhaler triple therapy: the TRIWIN study

Paschalis Steiropoulos  1 , Niki Georgatou  2 , George Krommidas  3 , Konstantinos Bartziokas  4 , Aliki Korkontzelou  5 , Panos Katerelos  6 , Petros Efstathopoulos  7 , Dimosthenis Papapetrou  2 , Stavros Theodorakis  8 , Konstantinos Porpodis  9
Affiliations
Observational Study

Extrafine single inhaler triple therapy effectiveness in COPD patients previously treated with multiple-inhaler triple therapy: the TRIWIN study

Paschalis Steiropoulos et al. Ther Adv Respir Dis. 2024 Jan-Dec.

Abstract

Background: The extrafine single inhaler triple therapy (efSITT) containing beclomethasone dipropionate/formoterol fumarate/glycopyrronium 87/5/9 μg has proved to be efficacious in patients with chronic obstructive pulmonary disease (COPD) in randomized control trials.

Objective: TRIWIN study evaluated the effectiveness of efSITT delivering beclomethasone dipropionate/formoterol fumarate/glycopyrronium 87/5/9 μg in COPD patients previously treated with multiple-inhaler triple therapy (MITT) in a real-world study in Greece.

Design: Prospective, multicenter, observational, non-interventional study was conducted over 24 weeks.

Methods: A total of 475 eligible patients had moderate-to-severe COPD, an indication for treatment with efSITT, and were symptomatic despite receiving MITT. COPD Assessment Test (CAT) score, pulmonary function parameters, use of rescue medication, and adherence to inhaler use were recorded at baseline (Visit 1), 3 (Visit 2), and 6 months (Visit 3) after treatment.

Results: Mean CAT score decreased from 21.4 points at Visit 1, to 16.6 at Visit 2 and 15.1 at Visit 3 (p < 0.001 for all pair comparisons). At Visit 3, 79.8% of patients reached a CAT improvement exceeding minimal clinically important difference (⩾2), compared to baseline. Mean forced expiratory volume in 1 s (%pred.) increased from 55.4% at Visit 1 to 63.5% at the end of study period (p < 0.001), while mean forced vital capacity (%pred.) increased from 71.1% at Visit 1, to 76.7% at Visit 3 (p < 0.001). The mean Test of Adherence to Inhalers score increased from 42.5 to 45.3 and 46.3 points, for the three visits, respectively (p < 0.001 comparing Visits 1/2 and Visits 1/3; p = 0.006 comparing Visits 2/3). The percentage of patients showing good adherence rose from 33.7% at baseline to 58.3% at Visit 3. The percentage of patients using rescue medication during the last month dropped from 16.2% to 7.4% at the end of study period (p < 0.001). Pulmonary function parameters also improved.

Conclusion: The TRIWIN results suggest that extrafine beclomethasone dipropionate/formoterol fumarate/glycopyrronium is effective in improving health status, pulmonary function, and adherence and in reducing rescue medication use in COPD patients previously treated with MITT, in a real-world setting in Greece.

Keywords: COPD; extrafine; health status; multiple-inhaler triple therapy; real-world study; single inhaler triple therapy; treatment adherence.

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Conflict of interest statement

PS reports honoraria from Astrazeneca, Chiesi, GSK, ELPEN, Menarini, and Novartis and consultancy fees from Astrazeneca, Chiesi, GSK, ELPEN, Menarini, Novartis, and Specialty Therapeutics. NG reports honoraria from Astrazeneca, Menarini, Boehringer, GSK, and MSD, consultancy fees from: Astrazeneca, Novartis, and Menarini, fees for participation in clinical trials from Astrazeneca, Boehringer Ingelheim, Chiesi, Menarini, Novartis, and GSK, as well as coverage of participation in national and international congresses. GK reports honoraria and consultancy fees from Astrazeneca, Chiesi, Elpen, GSK, Menarini, Novartis, Pharmaten, and Sanofi. KB reports honoraria and consultancy fees from: Astrazeneca, Chiesi, ELPEN, GSK, Menarini, and Novartis. AK was employed by Chiesi Hellas during this study execution, manuscript preparation, and submission and is currently an Astrazeneca Greece employee. PE and ST are employees of Chiesi Hellas S.A. PK reports financial support as statistical analyst of the present study. DP reports consultancy fees from: Chiesi, ELPEN, Innovis, Menarini, and Roche, honoraria from: Astrazeneca and Menarini, coverage of participation costs (registration, travel, and accommodation) in national and international congresses from: Astrazeneca, Bayer, Boehringer Ingelheim, Chiesi, ELPEN, Lilly, Menarini, Novartis, Pfizer, and participation in clinical studies of Amgen, Astrazeneca, Boehringer Ingelheim, Chiesi, ELPEN, GSK, Menarini, Novartis, and Sanofi. KP reports honoraria and consultancy fees from: Astrazeneca, Boehringer Ingelheim, Chiesi, CSL Behring, ELPEN, Innovis, GSK, Menarini, Novartis, Pharmathen, Sanofi, Specialty Therapeutics, and UCB.

Figures

Figure 1.
Figure 1.
(a) Mean ± SD CAT scores on all study visits. Range of health status: from 0 for best to 40 for worst (p < 0.001 for all pair comparisons). (b) CAT items: mean differences between Visits 1 and 3. Range of health status: from 0 for best to 40 for worst. CAT, COPD Assessment Test; SD, standard deviation.
Figure 2.
Figure 2.
Mean ± SD FEV1% predicted and FVC% predicted, at Visits 1 and 3, p < 0.001 for both comparisons (N = 99 patients with spirometry data available at first and last Visit). FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; SD, standard deviation.
Figure 3.
Figure 3.
(a) TAI score at Visits 1, 2, and 3: Mean ± SD. Score ranges: 50 points = Good adherence, 46–49 points = Intermediate adherence, and ⩽45 points = Poor adherence. p < 0.001 for comparison between Visits 1/2 and p = 0.006 for comparison between Visits 2/3. (b) Percentage of patients demonstrating various adherence levels, as measured by TAI at Visits 1, 2, and 3. Score ranges: 50 points = Good adherence, 46–49 points = Intermediate adherence, and ⩽45 points = Poor adherence. SD, standard deviation; TAI, Test of Adherence to Inhalers.
Figure 4.
Figure 4.
(a) Percent (%) of patients who took rescue medication in the month prior to each study Visit. p < 0.001 for comparison between Visits 1/2 and 1/3, non-statistically significant for the comparison between Visits 2/3. (b) Mean ± SD of times of rescue medication use in the month prior to each study Visit. p < 0.001 for comparison between Visits 1/2 and 1/3, non-statistically significant for the comparison between Visits 2/3. SD, standard deviation.
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