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NCT Number: NCT05495698

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

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.

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Key information

Conditions

COPD Adherence, Medication Behavior Chronic Disease Disease Attributes Health Behavior Lung Diseases Lung Diseases, Obstructive Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, 3045PM, Netherlands

Location status: Recruiting

Location contact

Liz Cuperus, Drs

CONTACT

[email protected]

+31108935567

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

single-inhaler triple therapy (Trimbow)

Drug

Patients in the intervention group will receive the triple therapy in one inhaler in stead of multiple inhalers. The actual medication is the same.

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

Device

Patients in intervention group 2 will receive Trimbow and will use the health app of Curavista and the smart-inhaler of FindAir

multi-inhaler triple therapy (Qvar + Bevespi)

Drug

Patients in the intervention group will receive the triple therapy in multiple inhalers. The actual medication is the same.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. CCQ questionnaire

    Time frame: 12 months

    measures health status and can be used to assess health-related quality of life

  3. VAS score

    Time frame: 12 months

    a non-specific scale to score an outcome from 0 (not satisfied at all) to 10 (extremely satisfied)

  4. PIH-NL

    Time frame: 12 months

    12-item scale to measure self-management behaviour and knowledge of patients with chronic diseases as COPD

  5. WPAI

    Time frame: 12 months

    questionnaire to measure impairments in work and activities

  6. EQ-5D-5L

    Time frame: 12 months

    questionnaire to assess the health-status

  7. HLS-EU-Q16

    Time frame: 12 months

    assessment of patients' health literacy

  8. 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

  9. SABA use

    Time frame: 12 months

    Use of espace medication

Other outcomes

  1. Concentration of beclomethasone and formoterol in hair

    Time frame: 2-3 months

    In a subgroup of patients, beclomethasone and formoterol concentration in their hair will be measured

Study contacts

Contact information is provided by the study sponsor or research team.

Hans in 't Veen

CONTACT

[email protected]

+31104616800

Liz Cuperus

CONTACT

[email protected]

+31108935567

Sponsors and collaborators

Lead sponsor

Franciscus Gasthuis

Other

Registry information

Acronym: TRICOLON

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2022
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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