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

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.

Study Overview

• Status: Recruiting
• Conditions: Copd; Adherence, Medication
• Intervention / Treatment: Drug: multi-inhaler triple therapy (Qvar + Bevespi); Drug: single-inhaler triple therapy (Trimbow); Device: E-health application: Curavista app & FindAir e-device

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liz Cuperus; Phone Number: +31108935567; Email: l.cuperus@franciscus.nl
• Study Contact Backup: Name: Hans in 't Veen; Phone Number: +31104616800; Email: h.intveen@franciscus.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3045PM
      • Recruiting
      • Franciscus Gasthuis & Vlietland
      • Contact: Liz Cuperus, Drs; Phone Number: +31108935567; Email: l.cuperus@franciscus.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; multi-inhaler triple therapy (Qvar and Bevespi)	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.
Other: Intervention group 1; single-inhaler triple therapy (Trimbow)	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.
Other: Intervention group 2; single-inhaler triple therapy (Trimbow) + e-health applications	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to ICS therapy	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TAI questionnaire score	questionnaire that identifies non-adherence and gives insight in the barriers related to the use of inhalers in asthma and COPD	12 months
CCQ questionnaire	measures health status and can be used to assess health-related quality of life	12 months
VAS score	a non-specific scale to score an outcome from 0 (not satisfied at all) to 10 (extremely satisfied)	12 months
PIH-NL	12-item scale to measure self-management behaviour and knowledge of patients with chronic diseases as COPD	12 months
WPAI	questionnaire to measure impairments in work and activities	12 months
EQ-5D-5L	questionnaire to assess the health-status	12 months
HLS-EU-Q16	assessment of patients' health literacy	12 months
Number exacerbations	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	12 months
SABA use	Use of espace medication	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of beclomethasone and formoterol in hair	In a subgroup of patients, beclomethasone and formoterol concentration in their hair will be measured	2-3 months

Collaborators and Investigators

• Sponsor: Franciscus Gasthuis

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 21, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: FranciscusGasthuis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No