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

Publisher: SAGE Publications Country of Publication: England NLM ID: 101316317 Publication Model: Print Cited Medium: Internet ISSN: 1753-4666 (Electronic) Linking ISSN: 17534658 NLM ISO Abbreviation: Ther Adv Respir Dis Subsets: MEDLINE

Original Publication: London, UK : SAGE Publications

Beclomethasone*/administration & dosage ; Beclomethasone*/adverse effects ; Bronchodilator Agents*/administration & dosage ; Bronchodilator Agents*/adverse effects ; Formoterol Fumarate*/administration & dosage ; Glycopyrrolate*/administration & dosage ; Glycopyrrolate*/adverse effects ; Nebulizers and Vaporizers* ; Pulmonary Disease, Chronic Obstructive*/drug therapy ; Pulmonary Disease, Chronic Obstructive*/physiopathology ; Pulmonary Disease, Chronic Obstructive*/diagnosis; Aged ; Female ; Humans ; Male ; Middle Aged ; Administration, Inhalation ; Adrenergic beta-2 Receptor Agonists/administration & dosage ; Adrenergic beta-2 Receptor Agonists/adverse effects ; Drug Combinations ; Forced Expiratory Volume ; Glucocorticoids/administration & dosage ; Greece ; Lung/physiopathology ; Lung/drug effects ; Medication Adherence ; Muscarinic Antagonists/administration & dosage ; Muscarinic Antagonists/adverse effects ; Prospective Studies ; Severity of Illness Index ; Time Factors ; Treatment Outcome

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.

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

0 (Adrenergic beta-2 Receptor Agonists)
KGZ1SLC28Z (Beclomethasone)
0 (Bronchodilator Agents)
0 (Drug Combinations)
W34SHF8J2K (Formoterol Fumarate)
0 (Glucocorticoids)
V92SO9WP2I (Glycopyrrolate)
0 (Muscarinic Antagonists)

Date Created: 20240725 Date Completed: 20240725 Latest Revision: 20241210

20241211

PMC11301738

10.1177/17534666241263439

39049587