Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
Trial Parameters
Brief Summary
TRICOLON is an investigator initiated, prospective, interventional, open-label, randomized, real-world, multi-centre, 3-arms study in the Netherlands. The primary objective is to investigate in COPD patients if single-inhaler triple therapy (SITT) is superior to multi-inhaler triple therapy (MITT) in terms of adherence to inhaled corticosteroids (ICS) therapy and to investigate if SITT with e-health support is superior to MITT and SITT without e-health support.
Eligibility Criteria
Inclusion Criteria: * Clinical diagnosis of COPD for at least 1 year before the screening visit * Aged 40 years and older * An indication for triple therapy according to the treating physician (following the GOLD guideline 2021(2)). Could be step-up from dual therapy or currently receiving triple therapy (both MITT and SITT). * Owner of mobile device compatible with e-device app with access to internet (Android or iOS) * Willing to provide written informed consent * Current or ex-smoker Exclusion Criteria: * Inability to comply with study procedures or with study treatment * Insufficiently skilled in the Dutch language to be able to read and understand the app. Help by third party (family members) is allowed * Asthma as the predominant disease according to the investigator's opinion, a past history of asthma is allowed * Use of e-health application for COPD in the past six months * Patients with any other therapy that could interfere with the study drugs (according to the investigator'