CopdTRICOLONNCT05495698
Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
A study testing single-inhaler triple therapy (Trimbow), E-health application: Curavista app & FindAir e-device and multi-inhaler triple therapy (Qvar + Bevespi) in people with Copd and Adherence, Medication, run by Franciscus Gasthuis at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Copd, Adherence, Medication
- What is being tested?
- single-inhaler triple therapy (Trimbow), E-health application: Curavista app & FindAir e-device and multi-inhaler triple therapy (Qvar + Bevespi)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Dec 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, 3045PM
Liz Cuperus, Drs, +31108935567, l.cuperus@franciscus.nl
About this study
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.
- Conditions
- Copd, Adherence, Medication
- Being tested
- single-inhaler triple therapy (Trimbow), E-health application: Curavista app & FindAir e-device, multi-inhaler triple therapy (Qvar + Bevespi)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-inhaler triple therapy (Trimbow)Drug
Patients in the intervention group will receive the triple therapy in one inhaler in stead of multiple inhalers. The actual medication is the same.
E-health application: Curavista app & FindAir e-deviceDevice
Patients in intervention group 2 will receive Trimbow and will use the health app of Curavista and the smart-inhaler of FindAir
multi-inhaler triple therapy (Qvar + Bevespi)Drug
Patients in the intervention group will receive the triple therapy in multiple inhalers. The actual medication is the same.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | multi-inhaler triple therapy (Qvar and Bevespi) Receives: Drug: multi-inhaler triple therapy (Qvar + Bevespi) |
| Intervention group 1 | Other | single-inhaler triple therapy (Trimbow) Receives: Drug: single-inhaler triple therapy (Trimbow) |
| Intervention group 2 | Other | single-inhaler triple therapy (Trimbow) + e-health applications Receives: Drug: single-inhaler triple therapy (Trimbow); Device: E-health application: Curavista app & FindAir e-device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (9)
TAI questionnaire score
questionnaire that identifies non-adherence and gives insight in the barriers related to the use of inhalers in asthma and COPD
Measured: 12 months
CCQ questionnaire
measures health status and can be used to assess health-related quality of life
Measured: 12 months
VAS score
a non-specific scale to score an outcome from 0 (not satisfied at all) to 10 (extremely satisfied)
Measured: 12 months
PIH-NL
12-item scale to measure self-management behaviour and knowledge of patients with chronic diseases as COPD
Measured: 12 months
WPAI
questionnaire to measure impairments in work and activities
Measured: 12 months
EQ-5D-5L
questionnaire to assess the health-status
Measured: 12 months
HLS-EU-Q16
assessment of patients' health literacy
Measured: 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
Measured: 12 months
SABA use
Use of espace medication
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start13 Dec 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CopdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first group will receive multi-inhaler triple therapy (control group), the second group single inhaler triple therapy (intervention group 1) and the third group single inhaler triple therapy with extra digital support to increase therapy adherence (intervention group 2).
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Franciscus Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495698
- Sponsor's protocol ID
- FranciscusGasthuis
- Acronym
- TRICOLON
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2022
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cuperus LJA, van der Palen J, Aldenkamp A, van Huisstede A, Bischoff EWMA, van Boven JFM, Brijker F, Dik S, van Excel JAJM, Goosens M, van Hal PTW, Kuijvenhoven JC, Kunz LIZ, Vasbinder EC, Kerstjens HAM, In 't Veen JCCM; TRICOLON study group. Adherence to single inhaler triple therapy and digital inhalers in Chronic Obstructive Pulmonary Disease: a literature review and protocol for a randomized controlled trial (TRICOLON study). BMC Pulm Med. 2024 Jul 4;24(1):317. doi: 10.1186/s12890-024-03044-3.
PubMed 38965541
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05495698
- Acronym / sponsor ID
- TRICOLON / FranciscusGasthuis
- Conditions
- Copd, Adherence, Medication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Franciscus GasthuisUniversity, hospital or other
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The first group will receive multi-inhaler triple therapy (control group), the second group single inhaler triple therapy (intervention group 1) and the third group single inhaler triple therapy with extra digital support to increase therapy adherence (intervention group 2).
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Drug: multi-inhaler triple therapy (Qvar + Bevespi)multi-inhaler triple therapy (Qvar and Bevespi) |
| Intervention group 1 | Other | Drug: single-inhaler triple therapy (Trimbow)single-inhaler triple therapy (Trimbow) |
| Intervention group 2 | Other | Drug: single-inhaler triple therapy (Trimbow), Device: E-health application: Curavista app & FindAir e-devicesingle-inhaler triple therapy (Trimbow) + e-health applications |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single-inhaler triple therapy (Trimbow)Patients in the intervention group will receive the triple therapy in one inhaler in stead of multiple inhalers. The actual medication is the same. | Drug | Intervention group 1, Intervention group 2 |
| E-health application: Curavista app & FindAir e-devicePatients in intervention group 2 will receive Trimbow and will use the health app of Curavista and the smart-inhaler of FindAir | Device | Intervention group 2 |
| multi-inhaler triple therapy (Qvar + Bevespi)Patients in the intervention group will receive the triple therapy in multiple inhalers. The actual medication is the same. | Drug | Control group |
Primary outcome
Adherence to ICS therapy
Time frame: 12 months
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
9 secondary outcomes
TAI questionnaire score
Time frame: 12 months
CCQ questionnaire
Time frame: 12 months
VAS score
Time frame: 12 months
PIH-NL
Time frame: 12 months
WPAI
Time frame: 12 months
EQ-5D-5L
Time frame: 12 months
HLS-EU-Q16
Time frame: 12 months
Number exacerbations
Time frame: 12 months
SABA use
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Derived from this study: PubMed 38965541Cuperus LJA, van der Palen J, Aldenkamp A, van Huisstede A, Bischoff EWMA, van Boven JFM, Brijker F, Dik S, van Excel JAJM, Goosens M, van Hal PTW, Kuijvenhoven JC, Kunz LIZ, Vasbinder EC, Kerstjens HAM, In 't Veen JCCM; TRICOLON study group. Adherence to single inhaler triple therapy and digital inhalers in Chronic Obstructive Pulmonary Disease: a literature review and protocol for a randomized controlled trial (TRICOLON study). BMC Pulm Med. 2024 Jul 4;24(1):317. doi: 10.1186/s12890-024-03044-3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single-inhaler triple therapy (Trimbow), E-health application: Curavista app & FindAir e-device and multi-inhaler triple therapy (Qvar + Bevespi) in people with Copd and Adherence, Medication, run by Franciscus Gasthuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liz Cuperus (+31108935567, l.cuperus@franciscus.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to ICS therapy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.