RecruitingNot ApplicableNCT05495698

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


Sponsor

Franciscus Gasthuis

Enrollment

300 participants

Start Date

Dec 13, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a single inhaler device (containing three medications) for COPD is more convenient and leads to better adherence than using multiple inhalers, and whether adding a digital app helps further. COPD (chronic obstructive pulmonary disease) is a lung condition that causes breathing difficulties. The triple therapy used in this study combines an inhaled corticosteroid, a long-acting beta-agonist, and a long-acting muscarinic antagonist. **You may be eligible if...** - You have had a diagnosis of COPD for at least 1 year - You are 40 or older - Your doctor has recommended triple therapy for your COPD - You are a current or ex-smoker - You own a smartphone (Android or iOS) with internet access - You are willing to give written consent **You may NOT be eligible if...** - You are unable to follow the study procedures - You cannot read or use the app in Dutch - Asthma is your main lung diagnosis - You used a digital health app for COPD in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGsingle-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.

DEVICEE-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

DRUGmulti-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

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NCT05495698


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