Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2024 Feb 23:19:475-487.
doi: 10.2147/COPD.S445858. eCollection 2024.

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

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 Piraino  11
Affiliations
Observational Study

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

Luca Richeldi et al. Int J Chron Obstruct Pulmon Dis. .

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: adherence; beclometasone/formoterol/glycopyrronium; chronic obstructive pulmonary disease; fixed triple therapy; patient-reported outcomes; real-world.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Change in mean total Chronic obstructive pulmonary disease Assessment Test score from baseline to 12 months.
Figure 2
Figure 2
Changes in CAT subcategories from baseline to 12 months.
Figure 3
Figure 3
Change in mean TAI-10 score from baseline to 12 months.
Figure 4
Figure 4
Change in mean EQ-5D Index (A) and VAS (B) from baseline to 12 months.
Figure 5
Figure 5
Change in mean CASIS score from baseline to 12 months.
Figure 6
Figure 6
Change in proportion of exacerbating patients before and after treatment with BDP/FF/G.
See this image and copyright information in PMC

References

    1. Agustí A, Celli BR, Criner GJ, et al. Global initiative for chronic obstructive lung disease 2023 report: GOLD executive summary. Eur Respir J. 2023;61(4):2300239. doi:10.1183/13993003.00239-2023 - DOI - PMC - PubMed
    1. EMA. Trimbow summary of product characteristics. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/trimbow. Accessed February 9, 2024.
    1. Singh D, Papi A, Corradi M, et al. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting β2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Lancet. 2016;388(10048):963–973. doi:10.1016/S0140-6736(16)31354-X - DOI - PubMed
    1. Vestbo J, Papi A, Corradi M, et al. Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial. Lancet. 2017;389(10082):1919–1929. doi:10.1016/S0140-6736(17)30188-5 - DOI - PubMed
    1. Papi A, Vestbo J, Fabbri L, et al. Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial. Lancet. 2018;391(10125):1076–1084. doi:10.1016/S0140-6736(18)30206-X - DOI - PubMed

Publication types