Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Franciscus Gasthuis & Vlietland
RECRUITING
Rotterdam
Contact Information
Primary
Liz Cuperus
l.cuperus@franciscus.nl
+31108935567
Backup
Hans in 't Veen
h.intveen@franciscus.nl
+31104616800
Time Frame
Start Date: 2022-12-13
Estimated Completion Date: 2026-12
Participants
Target number of participants: 300
Treatments
Other: Control group
multi-inhaler triple therapy (Qvar and Bevespi)
Other: Intervention group 1
single-inhaler triple therapy (Trimbow)
Other: Intervention group 2
single-inhaler triple therapy (Trimbow) + e-health applications
Sponsors
Leads: Franciscus Gasthuis

This content was sourced from clinicaltrials.gov