COPD self-management app test to see if it helps people get the best medication and control symptoms
Official title: To Explore the Safety and Clinical Efficacy of a Treatment Realignment Algorithm Using Data From a Digital Self-management Application for Patients With COPD
Run by University of Southampton · NCT07797985 · Data updated 2026-11-12
This trial tests whether the mySMARTCOPD app with an algorithm can help adults with COPD use the most appropriate inhaled therapy to control symptoms and reduce flare-ups.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 746 (estimated) |
| Sponsor | University of Southampton Academic / other |
| Locations | 1 site (Southampton, England) |
| Status | Recruiting |
| Started | October 8, 2025 |
| Main results expected | September 2026 |
| Study ends | September 2026 |
| Registry record updated | September 1, 2026 |
| Trial ID | NCT07797985 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 and older with COPD who actively use the myCOPD app, have recent CAT scores and exacerbation/medication data, and are able to provide informed consent.
✕Probably not a fit
Patients whose COPD is not responsive to guideline-based inhaled therapy or who have contraindications to the prescribed medications may derive little or no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label randomized trial includes a pilot phase and a larger efficacy phase to evaluate a treatment-realignment algorithm within the MMH-LAB1 app for COPD management. Participants are adults with COPD who use the myCOPD app and have recent symptom and medication data recorded in the app. The study aims to determine safety, acceptability, engagement, and efficacy in guiding guideline-based inhaled therapy to improve symptom control and reduce exacerbations, with a qualitative sub-study exploring patient experience. Phase 1 uses an interim futility analysis on adherence to intervention advice, followed by Phase 2 assessing efficacy and safety in a larger cohort. The study is led by the University of Southampton at University Hospital Southampton, with patients recruited in the UK.
Why it matters
Potential benefit: If successful, participants could experience better symptom control and fewer COPD flare-ups through optimized inhaled therapy guided by the app.
How similar studies have gone: Prior digital health trial work with COPD apps has shown potential for improving disease management, but this specific realignment algorithm and open-label design are relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients over 18 years of age and able to give informed consent 2. A clinical diagnosis of COPD (all patients registered on the app have a confirmed diagnosis of COPD confirmed by their clinician before being prescribed the app). 3. A registered and activated user of the myCOPD app 4. One or more CAT questionnaire completed on the myCOPD app in the last 12 months 5. One or more exacerbation form completed on the myCOPD app in the last 12 months CTU/FORM/5321 - CIP template for Clinical Investigations of Medical Devices, Version 1 14-DEC-2023 mySmartCOPD Clinical Investigation Plan v1 25-FEB-2025 Page 25 of 53 6. One or more COPD medication diary completed on the myCOPD app in the last 12 months 7. Classified appropriately into 3 groups: (A) Few symptoms (CAT \<10, 0 or 1 moderate exacerbations) (B) Many symptoms (CAT ≥10, ≥0 or 1 moderate exacerbations) (C)Exacerbators (≥2 moderate or ≥1 severe exacerbation independent of CAT) Exclusion Criteria: 8. Cannot read or write in English as required to understand the trial materials and provide the trial data. 9. Has not opted in to the research agreement via MyCOPD
Where it's running
-
University Hospital Southampton
Southampton, England, United Kingdom Recruiting
Study contacts
- Study coordinator: Trial Manager
- Email: mysmartcopd@soton.ac.uk
- Phone: +44 23 8059 6920
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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.