The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease (COPD) in an Italian Context of Real Life: The TRITRIAL Study Protocol

Abstract

Background

The fixed triple combination Beclometasone dipropionate/Formoterol fumarate/Glycopyrronium (BDP/FF/G, Trimbow^®), an extrafine formulation in a unique pressurized metered dose inhaler, is indicated for the maintenance treatment in adult patients with moderate to severe COPD, not adequately treated by ICS/LABA or LABA/LAMA. Besides the evidence from three randomized controlled trials, the impact of fixed triple therapy has not been extensively evaluated in a real-world population of COPD patients. TRITRIAL (TRIple Therapy in Real life: Impact on Adherence and HeaLth status) is a non-interventional study to assess the effect of BDP/FF/G in a real world setting in Italy.

Design

TRITRIAL is a 12-month, multicenter, cohort, prospective, longitudinal observational study. Two follow-up visits will be performed at 6 and 12 months, respectively. The study includes the collection of anamnestic clinical and functional data before the start of BDP/FF/G. The study is built for digital conduction, from signature of the informed consent on a dedicated web platform, to the collection of questionnaires and clinical data on the eCRF.

Population

A total of 800 patients with COPD ranging from Global Initiative for Obstructive Lung Disease (GOLD) stages 2 to 4, receiving therapy with BDP/FF/G according to the Summary of Product Characteristics and local clinical practice, will be recruited. All concomitant therapies will be permitted for the duration of the study.

Evaluations

The primary endpoint is the change of CAT score at 12 months versus baseline. Secondary endpoints are adherence, health-related quality of life, sleep quality, disease-related outcomes (lung function and COPD exacerbations), device usability, economic resources consumption, and safety.

Conclusion

TRITRIAL study is expected to give relevant information about effectiveness of BDP/FF/G fixed triple therapy in a real-life setting of patients with COPD, where adherence, usability of inhalers and patient’s preference of the device are crucial factors for the success of the therapy.

Keywords:

• COPD
• symptoms
• health status
• adherence
• LAMA
• LABA
• ICS

Abbreviations

BDP, Beclometasone dipropionate; BMI, body mass index; CASIS, COPD and Asthma Sleep Impact Scale; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; eCRF, electronic Case Report Form; FAS, Full Analysis Set; FF, Formoterol fumarate; G, Glycopyrronium; GOLD, Global Initiative for Chronic Obstructive Lung Disease; HRQoL, health-related quality of life; ICS, inhaled corticosteroids; ITT, intention-to-treat; LABA, long-acting beta2-agonists; LAMA, Long-acting muscarinic antagonists; LOCF, last observation carried forward; MMAD, mass median aerodynamic diameter; pMDI, pressurized metered dose inhaler; PROs, patient reported outcomes; QALY, quality-adjusted life years; RMC, Respiratory Medicine Centers; SAD, small airway dysfunction; SAF, Safety Analysis Set; SD, standard deviation; SGRQ, Saint George Respiratory Questionnaire; TAI, Test of Adherence to Inhalers.

Acknowledgments

The TRITRIAL Study is sponsored by Chiesi Italia. Editorial support was provided by Ethos srl and was funded by Chiesi Farmaceutici.

Disclosure

LR has received grants/research supports from Roche and Boehringer Ingelheim; he has received honoraria or consultation fees from Boehringer Ingelheim, Promedior, Biogen, FibroGen, Sanofi-Aventis, Promedior, RespiVant, Roche, Celgene, Nitto, and Veracyte. FM declares no conflict of interests. AP, EI and GM are employees of Chiesi Italia, Parma, Italy. The authors report no other conflicts of interest in this work.