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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - Current or ex-smoker Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

single-inhaler triple therapy (Trimbow)

Patients in the intervention group will receive the triple therapy in one inhaler in stead of multiple inhalers. The actual medication is the same.

DEVICE

E-health application: Curavista app & FindAir e-device

Patients in intervention group 2 will receive Trimbow and will use the health app of Curavista and the smart-inhaler of FindAir

DRUG

multi-inhaler triple therapy (Qvar + Bevespi)

Patients in the intervention group will receive the triple therapy in multiple inhalers. The actual medication is the same.

Locations (1)

Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, Netherlands