The following is a summary of “Adherence to Single Inhaler Triple Therapy and Digital Inhalers in Chronic Obstructive Pulmonary Disease: A Literature Review and Protocol for a Randomized Controlled Trial (TRICOLON study),” published in the July 2024 issue of Pulmonology by Cuperus et al.

Medication non-adherence represents a significant challenge in the management of Chronic Obstructive Pulmonary Disease (COPD). To combat this issue, healthcare strategies have increasingly focused on simplifying treatment regimens through single-inhaler triple therapy (SITT) and using smart inhalers as alternatives to the more complex multi-inhaler triple therapy (MITT). Despite their potential, the actual impact of these innovations on patient adherence and clinical outcomes remains to be determined. To bridge this knowledge gap, researchers conducted a comprehensive literature review addressing two critical questions: the comparative adherence rates between SITT and MITT users in COPD, and the influence of smart inhalers on adherence in COPD. Separate searches were executed in PubMed, and two independent reviewers assessed the relevant studies. 

Additionally, the study group proposed a study protocol designed to address identified research gaps. The literature review yielded eight observational trials concerning the first research question, indicating a lack of randomized controlled trials (RCTs). Seven of these trials demonstrated higher adherence and persistence among SITT users compared to MITT users, with four studies also reporting improved clinical outcomes associated with SITT. Eleven trials were reviewed for the second research question, showing a generally positive impact of smart inhalers on adherence, although results varied regarding their effect on clinical outcomes. To further investigate these findings, the TRICOLON (TRIple therapy COnvenience by the use of one or multiple Inhalers and digital support in Chronic Obstructive Pulmonary Disease) trial has been designed. 

This open-label, randomized, multi-center study aims to enhance the understanding of SITT and smart inhalers in improving adherence among COPD patients. A total of 300 patients requiring triple therapy will be randomized into three groups: MITT, SITT, and SITT, with digital support via a smart inhaler and an e-health platform. The study will span ten hospitals, with a follow-up period of one year. Adherence will be measured through smart inhaler data, self-reported adherence via the Test of Adherence to Inhalers (TAI) questionnaire, and drug analysis of scalp hair samples. Clinical outcomes will also be compared across the groups. Preliminary findings from the review suggest that SITT and smart inhalers may improve adherence, yet the current evidence is limited by the absence of RCTs and short follow-up durations. 

The TRICOLON trial seeks to provide robust data on these adherence-promoting strategies, utilizing a well-designed RCT to evaluate their effectiveness while minimizing disruption to participants’ daily lives. This trial will critically assess the practicality of SITT and smart inhalers, aiming to substantiate their roles in mitigating non-adherence in COPD management.

Source: bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-024-03044-3