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.
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)
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
Parallel
single-inhaler triple therapy (Trimbow)
DrugPatients in the intervention group will receive the triple therapy in one inhaler in stead of multiple inhalers. The actual medication is the same.
E-health application: Curavista app & FindAir e-device
DevicePatients in intervention group 2 will receive Trimbow and will use the health app of Curavista and the smart-inhaler of FindAir
multi-inhaler triple therapy (Qvar + Bevespi)
DrugPatients in the intervention group will receive the triple therapy in multiple inhalers. The actual medication is the same.
Adherence to ICS therapy
average adherence to ICS therapy (expressed as a percentage, measured as the number of actuations registered by the e-device divided by the total number of prescribed doses) over 12 months of treatment
TAI questionnaire score
questionnaire that identifies non-adherence and gives insight in the barriers related to the use of inhalers in asthma and COPD
CCQ questionnaire
measures health status and can be used to assess health-related quality of life
VAS score
a non-specific scale to score an outcome from 0 (not satisfied at all) to 10 (extremely satisfied)
PIH-NL
12-item scale to measure self-management behaviour and knowledge of patients with chronic diseases as COPD
Concentration of beclomethasone and formoterol in hair
In a subgroup of patients, beclomethasone and formoterol concentration in their hair will be measured
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