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Recruiting NCT05495698

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

No phase Interventional Copd Adherence, Medication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: single-inhaler triple therapy (Trimbow), E-health application: Curavista app & FindAir e-device, multi-inhaler triple therapy (Qvar + Bevespi).
Who it may be relevant to
Registry conditions: Copd, Adherence, Medication. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

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.

Primary outcome measures

  • Adherence to ICS therapy [Time frame: 12 months]
Secondary outcome measures (9)
  • TAI questionnaire score [Time frame: 12 months]
  • CCQ questionnaire [Time frame: 12 months]
  • VAS score [Time frame: 12 months]
  • PIH-NL [Time frame: 12 months]
  • WPAI [Time frame: 12 months]
  • EQ-5D-5L [Time frame: 12 months]
  • HLS-EU-Q16 [Time frame: 12 months]
  • Number exacerbations [Time frame: 12 months]
  • SABA use [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Netherlands · 1 center
  • Franciscus Gasthuis & Vlietland — Rotterdam

Publications

  • Cuperus LJA, van der Palen J, Aldenkamp A, van Huisstede A, Bischoff EWMA, van Boven JFM, Brijker F, Dik S, van Excel JAJM, Goosens M, van Hal PTW, Kuijvenhoven JC, Kunz LIZ, Vasbinder EC, Kerstjens HAM, In 't Veen JCCM; TRICOLON study group. Adherence to single inhaler triple therapy and digital inhalers in Chronic Obstructive Pulmonary Disease: a literature review and protocol for a randomized c PMID 38965541

Identifiers

NCT: NCT05495698 · FranciscusGasthuis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗