Comparing single and multiple inhalers with digital support for COPD management
Official title: Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
Run by Franciscus Gasthuis · NCT05495698 · Data updated 2026-11-12
This study is testing whether using one inhaler instead of multiple ones, along with digital support, helps people with COPD stick to their medication better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Franciscus Gasthuis Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Status | Recruiting |
| Started | December 13, 2022 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | August 21, 2025 |
| Trial ID | NCT05495698 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 40 and older with a clinical diagnosis of COPD who are indicated for triple therapy.
✕Probably not a fit
Patients who are unable to comply with study procedures or have asthma as the predominant disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of single-inhaler triple therapy (SITT) versus multi-inhaler triple therapy (MITT) in patients with Chronic Obstructive Pulmonary Disease (COPD). It aims to determine if SITT improves adherence to inhaled corticosteroids compared to MITT, and whether the addition of e-health support enhances this adherence further. The study is conducted in multiple centers across the Netherlands and involves a randomized, open-label design to assess real-world outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved medication adherence and better management of COPD for patients.
How similar studies have gone: Previous studies have shown promise in improving adherence through simplified inhaler regimens and digital support, suggesting this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, Netherlands Recruiting
Study contacts
- Study coordinator: Liz Cuperus
- Email: l.cuperus@franciscus.nl
- Phone: +31108935567
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.