Respiration DisordersPhase 1mySmartCOPDNCT07797985
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.
A Phase 1 study testing MMH-LAB1 app in people with Respiration Disorders, run by University of Southampton at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiration Disorders
- What is being tested?
- MMH-LAB1 app
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 746 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Oct 2025to Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Southampton
Southampton, England, SO16 6YD
Tom Wilkinson, MA Cantab MBBS PhD FRCP FERS, 02381 205341, T.Wilkinson@soton.ac.uk
About this study
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
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.
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.
Read the detailed description
This study is an open-label randomised control trial with inbuilt pilot phase and qualitative sub-study:
Phase 1 (pilot - 50 participants): Interim futility analysis on adherence to intervention advice Phase 2 (efficacy - 746 participants (including pilot phase participants): Safety acceptability and efficacy of intervention. This includes the qualitative sub study 15-20 participants (from the 746 Phase 2 participants).
Qualitative Sub-study: Acceptability of the intervention (15-20 intervention participants)
This trial will explore whether the introduction of the treatment realignment algorithm 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. To assess effect of the intervention on patients' symptom control, including exacerbation frequency and patient wellness scores.
Main objectives
- To understand the intervention pathway in the pilot phase and to identify additional patient support mechanisms for the efficacy phase in order to maximise healthcare equality
- To assess the levels of app usage and engagement
- To assess patients' experience of using the intervention
Study Design:
Open-Label Randomised Control Trial with inbuilt pilot phase Qualitative Sub study:
Phase 1 (Pilot): Interim futility analysis on adherence to intervention advice Phase 2 (Efficacy): Safety, acceptability and efficacy of intervention Qualitative Sub-study: Acceptability of the intervention.
The research question is to explore the safety and efficacy of the treatment re-alignment algorithm as part of a digital self-management application (app) in patients with COPD.
- Conditions
- Respiration Disorders
- Being tested
- MMH-LAB1 app
- Keywords
- Chronic Obstructive Pulmonary Disorder
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMH-LAB1 appDevice
This app is based on a COPD self management app, which they are already using and includes an algorithm which will notify participants if there is a discrepancy between the symptoms they report onto the app and their medication regime, and informs them to approach their healthcare provider for a medication review
| Study group | Role | What they receive |
|---|---|---|
| MMH-LAB1 Control This arm is based on the original COPD app the participants already use | Placebo comparator | 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 Receives: Device: MMH-LAB1 app |
| MMH-LAB1 Test This arm is based on the original COPD app the participants use plus an algorithm | Experimental | 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. Receives: Device: MMH-LAB1 app |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety, acceptability and efficacy of a digital treatment guidance algorithm for inhaled treatment in patients with COPD. The intention is to measure the impact of the algorithm in prompting patients to achieve optimal management, and t
Proportion (measured in %) of participants receiving guideline adherent treatment at Baseline and trial completion (Month 6). Range 0%-100%.
Measured: 6 months
Secondary outcomes (8)
To assess effect of intervention on exacerbation frequency and patient wellness scores
- Change in COPD Assessment Test (CAT) score between Baseline and trial completion (Month 6)
CAT test results 0 minimal symptom impact - Best and 40 maximum symptom impact
All will be described in terms of:
- Mean and SD
- Median and range and will be reported as descriptive stats
Measured: 6 months
To assess effect of the intervention on patients' adherence to guideline mandated treatment
- Rate of indication of algorithm to change treatment (0 times to 150 times)
- Rate if change in response to treatment change indication (0 times to 150 times)
All measured via frequency and percentage and description of change.
The combination of measurements will be reported as descriptive stats
Measured: 6 months
To understand the utility of the intervention pathway in the pilot phase and to identify additional patient support mechanisms for the efficacy phase in order to maximise healthcare equality
- % Patients receiving guideline adherent treatment at Baseline and trial completion (Month 6). 100% good. 0 % bad.
Above described qualitatively and in terms of % and frequency
Measured: 6 months
To assess the levels of app algorithm usage and engagement
-Frequency of app engagement
- Rate of completion of endpoint data
- Resource requirement to allow patients to act on intervention information
Measured by frequency (numbers of participant who completed everything) % (0% of expected use bad and 100% of expected use good). This will be reported as descriptive stats.
Measured: 6 months
To understand patients' experience of using the intervention
This section relates to the qualitative sub-study and will look at the following:
- Patient experience and patient and patient advocate feedback on experience of using app
- Patient satisfaction Rating using the Patient
Using feedback questionnaire at month 6 and qualitative interviews as part of the sub -study
- Qualitative data will be thematically analysed and written up in a report. Tables will be produced outlining key themes and illustrative quotes
- Frequency and percentage.
- Means and standard deviations.
- Statistical tests may be performed to explore any difference in experience of using the intervention relative to cohort groupings
This will be reported in a separate analysis document using qualitative research analysis and reporting techniques and norms
Measured: 3-6 months - interviews. 6 months - feedback questionnaire
To assess the safety of the algorithm
- Rate of algorithm inappropriately firing notifications
This is data collected via MMHLAB apps and qualitatively via patient advocate.
- Frequency and percentage. (0 times good, not maximum time - But anything over 0 is bad)
- Means and standard deviations.
Measured: 6 months
To assess the change in frequency of exacerbations
Frequency of exacerbation between Baseline and trial completion (Month 6) • Frequency and percentages (for number of exacerbations) Frequency will be measured from 0-150 with 0 being optimal. This will be reported as descriptive stats.
Measured: 6 months
To assess the change in Quality of Life between baseline and 6 months
Change in Quality of Life. Ratings measured using EQ-5D questionnaire between Baseline and trial completion (Month 6). All will be described in terms of: • Mean and SD • Median and range. Score 11111 will be classed as full health and 55555 will be classed worst health. This will be reported as descriptive stats
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start8 Oct 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Control Trial of an interventional device
- Masking
- None (open label)
- Enrolment
- 746 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797985
- Sponsor's protocol ID
- 355764
- Other IDs
- AI_Award02200
- Acronym
- mySmartCOPD
- Status last verified
- May 2026
- First submitted
- 7 May 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07797985
- Acronym / sponsor ID
- mySmartCOPD / 355764
- Conditions
- Respiration Disorders
- Keywords
- Chronic Obstructive Pulmonary Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 746 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Detailed description
This study is an open-label randomised control trial with inbuilt pilot phase and qualitative sub-study:
Phase 1 (pilot - 50 participants): Interim futility analysis on adherence to intervention advice Phase 2 (efficacy - 746 participants (including pilot phase participants): Safety acceptability and efficacy of intervention. This includes the qualitative sub study 15-20 participants (from the 746 Phase 2 participants).
Qualitative Sub-study: Acceptability of the intervention (15-20 intervention participants)
This trial will explore whether the introduction of the treatment realignment algorithm 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. To assess effect of the intervention on patients' symptom control, including exacerbation frequency and patient wellness scores.
Main objectives
- To understand the intervention pathway in the pilot phase and to identify additional patient support mechanisms for the efficacy phase in order to maximise healthcare equality
- To assess the levels of app usage and engagement
- To assess patients' experience of using the intervention
Study Design:
Open-Label Randomised Control Trial with inbuilt pilot phase Qualitative Sub study:
Phase 1 (Pilot): Interim futility analysis on adherence to intervention advice Phase 2 (Efficacy): Safety, acceptability and efficacy of intervention Qualitative Sub-study: Acceptability of the intervention.
The research question is to explore the safety and efficacy of the treatment re-alignment algorithm as part of a digital self-management application (app) in patients with COPD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Control Trial of an interventional device
| Arm | Type | Receives |
|---|---|---|
| MMH-LAB1 Control This arm is based on the original COPD app the participants already use | Placebo comparator | Device: MMH-LAB1 appParticipants 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 |
| MMH-LAB1 Test This arm is based on the original COPD app the participants use plus an algorithm | Experimental | Device: MMH-LAB1 appParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMH-LAB1 appThis app is based on a COPD self management app, which they are already using and includes an algorithm which will notify participants if there is a discrepancy between the symptoms they report onto the app and their medication regime, and informs them to approach their healthcare provider for a medication review | Device | MMH-LAB1 Control This arm is based on the original COPD app the participants already use, MMH-LAB1 Test This arm is based on the original COPD app the participants use plus an algorithm |
Primary outcome
To determine the safety, acceptability and efficacy of a digital treatment guidance algorithm for inhaled treatment in patients with COPD. The intention is to measure the impact of the algorithm in prompting patients to achieve optimal management, and t
Time frame: 6 months
Proportion (measured in %) of participants receiving guideline adherent treatment at Baseline and trial completion (Month 6). Range 0%-100%.
8 secondary outcomes
To assess effect of intervention on exacerbation frequency and patient wellness scores
Time frame: 6 months
To assess effect of the intervention on patients' adherence to guideline mandated treatment
Time frame: 6 months
To understand the utility of the intervention pathway in the pilot phase and to identify additional patient support mechanisms for the efficacy phase in order to maximise healthcare equality
Time frame: 6 months
To assess the levels of app algorithm usage and engagement
Time frame: 6 months
To understand patients' experience of using the intervention
Time frame: 3-6 months - interviews. 6 months - feedback questionnaire
To assess the safety of the algorithm
Time frame: 6 months
To assess the change in frequency of exacerbations
Time frame: 6 months
To assess the change in Quality of Life between baseline and 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MMH-LAB1 app in people with Respiration Disorders, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Manager (+44 23 8059 6920, mysmartcopd@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety, acceptability and efficacy of a digital treatment guidance algorithm for inhaled treatment in patients with COPD. The intention is to measure the impact of the algorithm in prompting patients to achieve optimal management, and t (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.