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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorFranciscus Gasthuis

About this trial

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

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • single-inhaler triple therapy (Trimbow)
  • E-health application: Curavista app & FindAir e-device
  • multi-inhaler triple therapy (Qvar + Bevespi)

Treatment groups

300 Participants
are divided into 3 treatment groups

Sponsors and collaborators