An interventional study of single-inhaler triple therapy (Trimbow) and E-health application: Curavista app & FindAir e-device in Copd and Adherence, Medication, sponsored by Franciscus Gasthuis. Recruiting at 1 site in Netherlands. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-08-21.
Sponsored by Franciscus Gasthuis · Not applicable, Interventional, and Other
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 300 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Franciscus Gasthuis is the lead sponsor of 18 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
multi-inhaler triple therapy (Qvar and Bevespi)
Drug: multi-inhaler triple therapy (Qvar + Bevespi)
single-inhaler triple therapy (Trimbow)
Drug: single-inhaler triple therapy (Trimbow)
single-inhaler triple therapy (Trimbow) + e-health applications
Drug: single-inhaler triple therapy (Trimbow) · Device: E-health application: Curavista app & FindAir e-device
Patients in the intervention group will receive the triple therapy in one inhaler in stead of multiple inhalers. The actual medication is the same.
Patients in intervention group 2 will receive Trimbow and will use the health app of Curavista and the smart-inhaler of FindAir
Patients in the intervention group will receive the triple therapy in multiple inhalers. The actual medication is the same.
Adherence to ICS therapy
average adherence to ICS therapy (expressed as a percentage, measured as the number of actuations registered by the e-device divided by the total number of prescribed doses) over 12 months of treatment
Time frame: 12 months
TAI questionnaire score
questionnaire that identifies non-adherence and gives insight in the barriers related to the use of inhalers in asthma and COPD
Time frame: 12 months
CCQ questionnaire
measures health status and can be used to assess health-related quality of life
Time frame: 12 months
VAS score
a non-specific scale to score an outcome from 0 (not satisfied at all) to 10 (extremely satisfied)
Time frame: 12 months
PIH-NL
12-item scale to measure self-management behaviour and knowledge of patients with chronic diseases as COPD
Time frame: 12 months
WPAI
questionnaire to measure impairments in work and activities
Time frame: 12 months
EQ-5D-5L
questionnaire to assess the health-status
Time frame: 12 months
HLS-EU-Q16
assessment of patients' health literacy
Time frame: 12 months
Number exacerbations
A moderate exacerbation is defined as sustained worsening of the patient's condition, from a stable state and beyond day-to-day variation, that is acute in onset and warrants additional treatment (systemic corticosteroids and/or antibiotics). An exacerbation is defined as severe if hospitalization or emergency department visit is necessary
Time frame: 12 months
SABA use
Use of espace medication
Time frame: 12 months
Concentration of beclomethasone and formoterol in hair
In a subgroup of patients, beclomethasone and formoterol concentration in their hair will be measured
Time frame: 2-3 months
Plan to share: Undecided
Started Dec 2022 (actual). Primary completion is estimated for Dec 2026, 48 months after the start.
Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 48 months is above that.
Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive →
Franciscus Gasthuis