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

Not Applicable

Recruiting

• Conditions: Copd; Adherence, Medication
• Interventions: Drug: single-inhaler triple therapy (Trimbow); Drug: multi-inhaler triple therapy (Qvar + Bevespi)

• Registration Number: NCT05495698
• Lead Sponsor: Franciscus Gasthuis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Study Start: 2022-12-13
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group 1	single-inhaler triple therapy (Trimbow)	single-inhaler triple therapy (Trimbow)
Control group	multi-inhaler triple therapy (Qvar + Bevespi)	multi-inhaler triple therapy (Qvar and Bevespi)
Intervention group 2	single-inhaler triple therapy (Trimbow)	single-inhaler triple therapy (Trimbow) + e-health applications

Primary Outcome Measures

Name	Time	Method
Adherence to ICS therapy	12 months	average adherence to ICS therapy (expressed as a percentage, measured as the number of actuations registered by the e-device divided by the total number of prescribed doses) over 12 months of treatment

Secondary Outcome Measures

Name	Time	Method
SABA use	12 months	Use of espace medication
VAS score	12 months	a non-specific scale to score an outcome from 0 (not satisfied at all) to 10 (extremely satisfied)
HLS-EU-Q16	12 months	assessment of patients' health literacy
EQ-5D-5L	12 months	questionnaire to assess the health-status
Number exacerbations	12 months	A moderate exacerbation is defined as sustained worsening of the patient's condition, from a stable state and beyond day-to-day variation, that is acute in onset and warrants additional treatment (systemic corticosteroids and/or antibiotics). An exacerbation is defined as severe if hospitalization or emergency department visit is necessary
TAI questionnaire score	12 months	questionnaire that identifies non-adherence and gives insight in the barriers related to the use of inhalers in asthma and COPD
CCQ questionnaire	12 months	measures health status and can be used to assess health-related quality of life
WPAI	12 months	questionnaire to measure impairments in work and activities
PIH-NL	12 months	12-item scale to measure self-management behaviour and knowledge of patients with chronic diseases as COPD

Trial Locations

Locations (1)

Franciscus Gasthuis & Vlietland; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands