NCT05495698Recruiting
Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov · Last updated 21 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 5 Aug 2022
- Start date
- 13 Dec 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Franciscus Gasthuis
- Diseases
- COPD
- NCT number
- NCT05495698
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 13 Dec 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with any other therapy that could interfere with the study drugs (according to the investigator's opinion)
Other illness
- Asthma as the predominant disease according to the investigator's opinion, a past history of asthma is allowed
Other
- 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
- Use of e-health application for COPD in the past six months
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Franciscus Gasthuis & Vlietland Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.