Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT05495698

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

Led by Franciscus Gasthuis · Updated on 2025-08-21

300

Participants Needed

1

Research Sites

207 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of COPD for at least 1 year before the screening visit
  • Age 40 years and older
  • Indication for triple therapy as determined by treating physician according to GOLD guideline 2021
  • Owner of mobile device compatible with e-device app with internet access (Android or iOS)
  • Willing to provide written informed consent
  • Current or ex-smoker
Not Eligible

You will not qualify if you...

  • Inability to comply with study procedures or treatment
  • Insufficient Dutch language skills to read and understand the app (family help allowed)
  • Asthma as predominant disease according to investigator; past history of asthma allowed
  • Use of e-health application for COPD in past six months
  • Use of any therapy interfering with study drugs per investigator
  • Use of nebulized bronchodilators, e.g., via pari boy
  • Pregnant or lactating women and women capable of becoming pregnant without highly effective contraception
  • Mentally or legally incapacitated patients or those under official/judicial accommodation
  • Inability to complete questionnaires

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, Netherlands, 3045PM

Actively Recruiting

Loading map...

Research Team

L

Liz Cuperus

CONTACT

H

Hans in 't Veen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here