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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | multi-inhaler triple therapy (Qvar and Bevespi) |
|
| Intervention group 1 | Other | single-inhaler triple therapy (Trimbow) |
|
| Intervention group 2 | Other | single-inhaler triple therapy (Trimbow) + e-health applications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| TAI questionnaire score | questionnaire that identifies non-adherence and gives insight in the barriers related to the use of inhalers in asthma and COPD | 12 months |
| CCQ questionnaire | measures health status and can be used to assess health-related quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of beclomethasone and formoterol in hair | In a subgroup of patients, beclomethasone and formoterol concentration in their hair will be measured | 2-3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liz Cuperus | Contact | +31108935567 | l.cuperus@franciscus.nl | |
| Hans in 't Veen | Contact | +31104616800 | h.intveen@franciscus.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franciscus Gasthuis & Vlietland | Recruiting | Rotterdam | South Holland | 3045PM | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38965541 | Derived | 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. |
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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).
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| E-health application: Curavista app & FindAir e-device | Device | 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. |
|
| 12 months |
| VAS score | a non-specific scale to score an outcome from 0 (not satisfied at all) to 10 (extremely satisfied) | 12 months |
| PIH-NL | 12-item scale to measure self-management behaviour and knowledge of patients with chronic diseases as COPD | 12 months |
| WPAI | questionnaire to measure impairments in work and activities | 12 months |
| EQ-5D-5L | questionnaire to assess the health-status | 12 months |
| HLS-EU-Q16 | assessment of patients' health literacy | 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 | 12 months |
| SABA use | Use of espace medication | 12 months |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
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