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

Abstract

Purpose

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 study.

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

Ethics Approval

All procedures performed were in accordance with the 1964 Helsinki Declaration and its later amendments, Good Clinical Practice and local applicable regulations. The present study was approved by the Ethics Committee of Policlinico Agostino Gemelli IRCCS (Rome) and all the centers involved in the study.

Data Sharing Statement

The data that support the findings of this study are available from the corresponding author, USA, upon reasonable request.

Consent to Participate

All subjects provided informed written consent prior to enrollment in the study.

Consent for Publication

All subjects provided informed written consent for the publication of their data.

Acknowledgments

Editorial assistance was provided by Ambra Corti, Aashni Shah, Valentina Attanasio and Massimiliano Pianta (Polistudium, Milan, Italy).

Author Contributions

Study conception and design: AP, EI, USA, LR; collection and interpretation of data: AP, EI, USA, LR, FM; statistical analysis: AP, EI, USA; manuscript drafting: AP, USA, EI. All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in revising or critically reviewing the article; agree on the journal to which the article will be submitted; agree all versions of the article before submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage; agree to take responsibility and be accountable for the contents of the article.

Disclosure

LR has received grants/research support 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. GC reports personal fees from Astra Zeneca, Sanofi, and GSK, outside the submitted work. AP, USA and EI are employees of Chiesi Italia, Parma, Italy. The other authors report no conflicts of interest in this work.

Additional information

Funding

The clinical study TRITRIAL is sponsored by Chiesi Italia S.p.A. The editorial assistance for the preparation of this manuscript is funded by Chiesi Italia S.p.A.