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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Copd Adherence, Medication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The first group will receive multi-inhaler triple therapy (control group), the second group single inhaler triple therapy (intervention group 1) and the third group single inhaler triple therapy with extra digital support to increase therapy adherence (intervention group 2).

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control group

multi-inhaler triple therapy (Qvar and Bevespi)

Group Type OTHER

multi-inhaler triple therapy (Qvar + Bevespi)

Intervention Type DRUG

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

Intervention group 1

single-inhaler triple therapy (Trimbow)

Group Type OTHER

single-inhaler triple therapy (Trimbow)

Intervention Type DRUG

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

Intervention group 2

single-inhaler triple therapy (Trimbow) + e-health applications

Group Type OTHER

single-inhaler triple therapy (Trimbow)

Intervention Type DRUG

Patients 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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DRUG

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

Intervention Type DEVICE

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No