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Taking people in United KingdomPhase 1

A phone app that reviews inhaler medicines for people with COPD

Tests an app checking inhaler medicines for people with COPD.

Key facts

Who runs it
University of Southampton
Where
Southampton, United KingdomSee the site
Trial code
Registry title
To Identify if a COPD Self-management App Can Safety and Appropriately Identify When Patients Are Not on the Best Medication Plan for Their COPD Symptoms and Support Their COPD Management.
Status
Recruiting
Phase
Phase 1
People taking part
746 people, planned
Started
8 Oct 2025
Planned end
Sept 2026
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • MMH-LAB1 app
Record updated
1 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with COPD who already use the myCOPD app and have recently logged symptoms, flare-ups and medications in it.

Age
18 years or older
Sex
All sexes can join.
Disease stage
A clinical diagnosis of COPD. People are sorted into 3 groups: few symptoms (CAT <10, 0 or 1 moderate exacerbations), many symptoms (CAT ≥10), or exacerbators (≥2 moderate or ≥1 severe exacerbation).
Earlier treatment
Must be a registered and activated user of the myCOPD app. Must have completed in the app in the last 12 months: one or more CAT questionnaire, one or more exacerbation form, one or more COPD medication diary.

Main reasons for not taking part

  • Cannot read or write in English
  • Has not opted in to the research agreement via MyCOPD
  • Cannot give informed consent

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • Adult patients over 18 years of age and able to give informed consent
  • 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)
  • A registered and activated user of the myCOPD app
  • One or more CAT questionnaire completed on the myCOPD app in the last 12 months
  • 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
  • One or more COPD medication diary completed on the myCOPD app in the last 12 months
  • 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)

Who cannot take part

  • Cannot read or write in English as required to understand the trial materials and provide the trial data
  • Has not opted in to the research agreement via MyCOPD

Where in United Kingdom

  • University Hospital SouthamptonSouthampton, United KingdomContact: Tom Wilkinson, MA Cantab MBBS PhD FRCP FERSTaking people

About the trial

What the trial wants to find out

Although COPD cannot be cured, managing COPD can help reduce symptoms control, slows progression of the disease, and may improve the quality of life. Management of COPD becomes less effective when healthcare professionals fail to prescribe appropriate inhaled therapies, due to poor adherence to evidence-based guidelines and underdiagnosis, or when patients fail to adhere to prescribed treatment regimens.

Read full original descriptionShow less

my mhealth has developed an app called myCOPD to allow patients to record their COPD symptoms and medications, which in term supports them with their COPD. This app is now used by COPD patients across the UK, via a prescription from their healthcare professionals. my mHealth has now developed a research app MMH-LAB1 which, in the intervention arm, includes an algorithm to assist patients with understanding their level of symptom burden according to the severity of their daily symptoms and exacerbation risk. The algorithm then analyses current patient prescribed inhaled medication against those recommended by the GOLD 2023 report and informs the patient via the MMH-LAB1 app as to whether their medication needs to be changed by their healthcare provider. This trial will explore whether the introduction of the algorithm within the MMH-LAB1 app can be used as a safe, effective and acceptable tool to assist patients to achieve optimal guideline based inhaled therapy and therefore provide greater symptom control and lowered exacerbation risk for COPD patients.

Participants will be randomised to the MMH-LAB1 app - control arm (MMH-LAB_Control_1 where participants just record COPD symptoms and medications), or to the MMH_LAB1 app - intervention arm (MMH-LAB1_Test_1 where participants record their COPD symptoms and medication plus receiving information from the algorithm, as to whether their medications are in guidance or not, and if not, be notified to visit their healthcare professional.

The 2 groups in the trial

  • MMH-LAB1 Control This arm is based on the original COPD app the participants already usePlacebo, for comparison

    Participants for this study are already users of a COPD self management app. This arm is a replica of this app, with additional questionnaires built in

    Treatment: MMH-LAB1 app

  • MMH-LAB1 Test This arm is based on the original COPD app the participants use plus an algorithmTreatment being tested

    Participants for this study are already users of a COPD self management app. This arm is a replica of this app, with additional questionnaires built in plus an algorithm which identifies, based on the symptoms and medication reported onto the app by the participant, whether they are on the correct medication or not. If not, the app will generate a notification and inform the participant that they need to approach their healthcare provider and inform them of this and that they need a medication review.

    Treatment: MMH-LAB1 app

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
A phone app that reviews inhaler medicines for people with COPDGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
1 September 2026