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Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease

RecruitingNAAges 40 Years - anyAllFranciscus Gasthuis
NCT05495698 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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's opinion) * Use of nebulized bronchodilators, for example via pari boy * Pregnant or lactating women and all women physiologically capable of becoming pregnant unless they have highly effective contraceptive * Patients mentally or legally incapacitated, or patients accommodated in an establishment as a result of an official or judicial order * Patients without the capability to complete the questionnaires
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What it tests

  • single-inhaler triple therapy (Trimbow)
  • E-health application: Curavista app & FindAir e-device
  • multi-inhaler triple therapy (Qvar + Bevespi)
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Where

1 site
Franciscus Gasthuis & Vlietland
Rotterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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