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

Last updated: October 2, 2023
Sponsor: Franciscus Gasthuis
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

single-inhaler triple therapy (Trimbow)

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

multi-inhaler triple therapy (Qvar + Bevespi)

Clinical Study ID

NCT05495698
FranciscusGasthuis
  • Ages > 40
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 theGOLD guideline 2021(2)). Could be step-up from dual therapy or currently receivingtriple therapy (both MITT and SITT).
  • Owner of mobile device compatible with e-device app with access to internet (Androidor iOS)
  • Willing to provide written informed consent
  • Current or ex-smoker

Exclusion

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 theapp. Help by third party (family members) is allowed
  • Asthma as the predominant disease according to the investigator's opinion, a pasthistory 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 (accordingto the investigator's opinion)
  • Use of nebulized bronchodilators, for example via pari boy
  • Pregnant or lactating women and all women physiologically capable of becoming pregnantunless they have highly effective contraceptive
  • Patients mentally or legally incapacitated, or patients accommodated in anestablishment as a result of an official or judicial order
  • Patients without the capability to complete the questionnaires

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: single-inhaler triple therapy (Trimbow)
Phase:
Study Start date:
December 13, 2022
Estimated Completion Date:
September 30, 2024

Connect with a study center

  • Franciscus Gasthuis & Vlietland

    Rotterdam, Zuid-Holland 3045PM
    Netherlands

    Active - Recruiting

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