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

Franciscus Gasthuis

Status: Enrolling

Conditions: Adherence, Medication; Copd

Treatments: Device: E-health application: Curavista app & FindAir e-device; Drug: single-inhaler triple therapy (Trimbow); Drug: multi-inhaler triple therapy (Qvar + Bevespi)

Study type: Interventional

Funder types: Other

Identifiers

NCT05495698

FranciscusGasthuis

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Control group

Other group

Description:

multi-inhaler triple therapy (Qvar and Bevespi)

Treatment:

Drug: multi-inhaler triple therapy (Qvar + Bevespi)

Intervention group 1

Other group

Description:

single-inhaler triple therapy (Trimbow)

Treatment:

Drug: single-inhaler triple therapy (Trimbow)

Intervention group 2

Other group

Description:

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

Treatment:

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

Drug: single-inhaler triple therapy (Trimbow)