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

Study Overview
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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.

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

Conditions
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Copd, Adherence, Medication

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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>multi-inhaler triple therapy (Qvar and Bevespi) | Drug: multi-inhaler triple therapy (Qvar + Bevespi)<br>* Patients in the intervention group will receive the triple therapy in multiple inhalers. The actual medication is the same.<br>|
| Other: Intervention group 1<br>single-inhaler triple therapy (Trimbow) | Drug: single-inhaler triple therapy (Trimbow)<br>* Patients in the intervention group will receive the triple therapy in one inhaler in stead of multiple inhalers. The actual medication is the same.<br>|
| Other: Intervention group 2<br>single-inhaler triple therapy (Trimbow) + e-health applications | Drug: single-inhaler triple therapy (Trimbow)<br>* Patients in the intervention group will receive the triple therapy in one inhaler in stead of multiple inhalers. The actual medication is the same.<br>Device: E-health application: Curavista app & FindAir e-device<br>* Patients in intervention group 2 will receive Trimbow and will use the health app of Curavista and the smart-inhaler of FindAir<br>|

What is the study measuring?
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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 |