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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2024

Interventions

  • 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
  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Adherence to ICS therapy
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Franciscus Gasthuis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Liz Cuperus, l.cuperus@franciscus.nl

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