A Phase 1 interventional study of MMH-LAB1 app in Respiration Disorders, sponsored by University of Southampton. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by University of Southampton · Phase 1, Interventional, and Supportive care
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.
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
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.
359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.
This study's planned enrollment of 746 is above the median of 69 across 216 interventional studies indexed under Respiration Disorders.
Browse Respiration Disorders studies →University of Southampton is the lead sponsor of 122 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: MMH-LAB1 app
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.
Device: MMH-LAB1 app
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
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%.
Time frame: 6 months
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
Time frame: 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
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
\- % 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Sep 2026, 11 months after the start.
Of 17 phase 1 interventional studies under Respiration Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
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