Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
Recruiting now · Not applicable
Conditions studied: Copd, Adherence, Medication
In brief
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.
Key facts
- Study ID
- NCT05495698
- Run by
- Franciscus Gasthuis
- People needed
- 300
- Starts
- 2022-12-13
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-08-21
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Franciscus Gasthuis & Vlietland — Rotterdam, South Holland, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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