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

Launched by FRANCISCUS GASTHUIS · Aug 8, 2022

Keywords

ClinConnect Summary

The TRICOLON clinical trial is studying different ways to help people with Chronic Obstructive Pulmonary Disease (COPD) stick to their inhaler treatments. Specifically, it looks at whether using one inhaler that combines three medications (called single-inhaler triple therapy or SITT) is better for patient adherence than using multiple inhalers (multi-inhaler triple therapy or MITT). It also explores if adding digital health support, like a mobile app, can make SITT even more effective compared to using multiple inhalers without that support.

To join the study, participants need to be at least 40 years old, have been diagnosed with COPD for at least a year, and have a doctor's recommendation for triple therapy. Participants should also own a smartphone that can run the required app. Those who are currently or were previously smokers are eligible, but people with severe asthma or certain other health conditions won't qualify. If you participate, you will use the assigned inhaler(s) and may receive support through a mobile app to help manage your treatment. This trial is currently recruiting patients in the Netherlands and aims to improve how COPD is managed for better health outcomes.

Gender

ALL

Eligibility 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