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

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Franciscus Gasthuis

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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