Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
Recruiting
N/AInterventional Study
CopdAdherence, Medication
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 and older
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
300 (estimated)
Sponsor
Franciscus Gasthuis · Other
Who this trial is looking for
This trial is looking for adults with chronic obstructive pulmonary disease (COPD) to see if using one inhaler is better than using multiple inhalers. Participants will also explore if digital support helps with their treatment.
Are You a Good Fit for This Trial?
Rules you outAsthma
You may be able to join if
I am 40 years old or older
I have been diagnosed with COPD for at least 1 year
My doctor says I need triple therapy for my COPD
I own a mobile device that can use an app and connect to the internet
I can give written consent to participate
I am a current or ex-smoker
You may not be able to join if
I cannot follow the study procedures
I don't understand Dutch well enough to use the app
I have asthma as my main disease
I have used a COPD e-health application in the past six months
I am using other treatments that could interfere with the study drugs
I use nebulized bronchodilators
I am pregnant or breastfeeding
I cannot complete the questionnaires
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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-heal…
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.
Trial Locations
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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 t…
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
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