Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
NCT05495698 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2025-08-21
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 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
Interventions
- DRUG
-
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.
- DEVICE
-
E-health application: Curavista app & FindAir e-device
Patients in intervention group 2 will receive Trimbow and will use the health app of Curavista and the smart-inhaler of FindAir
- DRUG
-
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.
Sponsors & Collaborators
-
Franciscus Gasthuis
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-13
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Netherlands
Study Locations
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