Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05495698

Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
300 (estimated)
Sponsor
Franciscus Gasthuis · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGsingle-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.
DEVICEE-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
DRUGmulti-inhaler triple therapy (Qvar + Bevespi)Patients in the intervention group will receive the triple therapy in multiple inhalers. The actual medication is the same.

Timeline

Start date
2022-12-13
Primary completion
2026-12-01
Completion
2026-12-01
First posted
2022-08-10
Last updated
2025-08-21

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT05495698. Inclusion in this directory is not an endorsement.