NCT05495698 Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
| NCT ID | NCT05495698 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Franciscus Gasthuis |
| Condition | Copd |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-12-13 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2022-12-13 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05495698 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Copd. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05495698 currently recruiting?
Yes, NCT05495698 is actively recruiting participants. Contact the research team at l.cuperus@franciscus.nl for enrollment information.
Where is the NCT05495698 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT05495698 clinical trial?
NCT05495698 is sponsored by Franciscus Gasthuis. The trial plans to enroll 300 participants.
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