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Luca Richeldi,1 Pietro Schino,2 Elena Bargagli,3 Alberto Ricci,4 Alberto Rocca,5 Francesca Marchesani,6 Alfio Pennisi,7 Gianna Camiciottoli,8,9 Maria D’Amato,10 Francesco Macagno,1 Ulrica Scaffidi Argentina,11 Eleonora Ingrassia,11 Alessio Piraino11 1Division of Pulmonary Medicine, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy; 2Miulli Hospital, Acquaviva Delle Fonti, Bari, Italy; 3Respiratory Diseases Unit, Department of Medical and Surgical Sciences, Neuro Sciences, Siena University Hospital, Siena, Italy; 4Department of Medical-Surgical Sciences and Translational Medicine, Via di Grottarossa 1035, Sapienza University of Rome, Rome, Italy; 5Department of Respiratory Medicine, Bellaria Hospital, Bologna, Italy; 6Division of Pneumology, Ospedale di Macerata, Macerata, Italy; 7Department of Respiratory Medicine, Hospital Clinic “Casa di Cura Riabilitativa Calaciura”, Catania, Italy; 8Department of Biomedical, Experimental and Clinical Sciences, University of Florence, Florence, Italy; 9Department of Cardiothoracovascular, Careggi University Hospital, Firenze, Italy; 10UOSD Malattie Respiratorie ”Federico II”, Ospedale Monaldi, Napoli, 80131, Italy; 11Medical Affairs, Chiesi Italia S.p.A, Parma, ItalyCorrespondence: Ulrica Scaffidi Argentina, Chiesi Italia S.P.A, Via Giacomo Chiesi 1, Parma, 43122, Italy, Tel +39 0521 1689690 ; +39 346 82 61 074, Email u.scaffidiargentina@chiesi.comPurpose: 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.Keywords: beclometasone/formoterol/glycopyrronium, chronic obstructive pulmonary disease, real-world, fixed triple therapy, adherence, patient-reported outcomes |
