Asthma ChronicNCT06364527
Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma
A study testing Aptar Digital Health respiratory disease management platform in people with Asthma Chronic, run by CoheroHealth at 1 site in United Kingdom.
Trial summary
The United Kingdom has a high prevalence of asthma (over 12%) and some of the worst health outcomes in Europe. The management of respiratory disease and associated patient outcomes has long been an area of focus and improvement for the National Health Service. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma Chronic
- What is being tested?
- Aptar Digital Health respiratory disease management platform
- Type of treatment
- Medical device
- How many people
- 94 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jul 2024to 27 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Age < 16 years
- FeNO < 35 ppb
- Known or suspected alcohol or drug abuse which in opinion of investigator could interfere with subject's proper completion of the protocol requirement
- History of life-threatening asthma: Defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within last 6 months
- A lower respiratory tract infection within 7 days of the screening visit ● Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other respiratory disorders including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
- History of hypersensitivity/intolerance to any components of the study inhalers (example, lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded.
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- Ever received treatment with biological based therapy example, omalizumab, mepolizumab, for asthma.
- Received an investigational drug and/or medical device within 30 days of entry into this study (Screening), or within five drug half-lives of the investigational drug, whichever is longer
- An immediate family member of the participating investigator, sub-investigator, study coordinator, employee of the participating investigator, or any family member of a Aptar Pharma, Aptar Digital Health, Voluntis, or Cohero employee.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St. Thomas' NHS Foundation Trust
London, England, SE1 9RT
About this study
Official title: Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma: A Pilot Study
The United Kingdom has a high prevalence of asthma (over 12%) and some of the worst health outcomes in Europe. The management of respiratory disease and associated patient outcomes has long been an area of focus and improvement for the National Health Service. With the advancement of digital health technology, there is the potential to transform patient care and improve outcomes.
The Aptar Digital Health respiratory disease management platform, a digital therapeutic will be utilized to determine its value and how it supports: i) asthma patient engagement and facilitates communication between patients and providers to accelerate medication adherence; ii) asthma control through the use of the Asthma Control Questionnaire-5. In addition, spirometry and fractioned exhaled nitric oxide will be utilized during the study to validate and enhance current National Institute for Health and Care Excellence guidelines.
Read the detailed description
This is an open-label, single comparative study that will accrue a total of 118 participants and compare pre and post study results. Group # 1 will consist of 59 participants with a fractioned exhaled nitric oxide ≥ 45 ppb and ≥ 3 exacerbations / year (biologic eligible). Group # 2 will consist of 59 participants with a fractioned exhaled nitric oxide ≥ 45 ppb and < 3 exacerbations / year (non-biologic eligible). At the baseline visit, clinic appointment # 1, health care providers will review the participants' medical records to determine clinical outcomes in the past year, including number of exacerbations, medication pharmacy refill percentage, and fractioned exhaled nitric oxide score. At the baseline visit, participants will also complete the Asthma Control Questionnaire-5 and the Mini-Asthma Quality of Life Questionnaire. The past year clinical evaluation and Asthma Control Questionnaire-5 and Mini-Asthma Quality of Life Questionnaire will be considered baseline results.
Patients will be screened for study appropriateness at the Guy's Hospital Severe Asthma Clinic. During the initial visit, which will be considered the study baseline visit, patients will be provided with the Aptar Digital Health respiratory disease management platform and trained to use the platform. Participants will be scheduled for in person follow-up visits at 1-2 months and then 6-months post-baseline; patients will be scheduled for virtual visits at 3-months post-baseline.
Patients will then be trained by Guy's Hospital team members; Aptar Digital Health staff will provide extensive training to the Guy's Hospital team prior to the study to ensure the team is fully knowledgeable about the product, its features, and can successfully onboard participants onto the Aptar Digital Health respiratory disease management platform. Once participants are trained, they will utilize the BreatheSmart mobile application by downloading it through either the Apple Store™ or Google Play™.
The BreatheSmart mobile application records, stores, and transmits usage events to the HeroTracker sensors, or via manual user entry, to a remote storage system. Participants may self-enter their medication schedule either with or without the help of their health care providers. Through the BreatheSmart mobile application, they can review information collected from the HeroTracker Sense metered dose inhaler and FindAir ONE dry powder inhaler sensors, report and review their adherence and self-reported symptoms, and answer validated questionnaires.
Participants can share the data entered through the BreatheSmart mobile application with caregivers and health care providers. Health care providers are then able to utilize BreatheSmart Connect, a web application, to obtain an overview of all participants utilizing the Aptar Digital Health respiratory disease management platform including detailed views of individual participant information. Health care providers can view real-time adherence, medication list, participants within and outside of risk zones (depending on adherence), rescue medication usage, symptoms, and triggers. Based on the information gleaned from the BreatheSmart Connect platform, clinicians will schedule follow-up participant appointments with either a junior or senior pharmacist at the Guy's Hospital Severe Asthma Clinic.
Participants will use the Aptar Digital Health respiratory disease management platform for 6 months and will be required to return the device upon study completion.
- Conditions
- Asthma Chronic
- Being tested
- Aptar Digital Health respiratory disease management platform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aptar Digital Health respiratory disease management platformDevice
The Aptar Digital Health respiratory disease management platform is a digital health tool that combines a Healthcare Professional portal (BreatheSmart Connect) and an associated patient mobile application (BreatheSmart mobile application). The Aptar Digital Health respiratory disease management platform is intended to be used in conjunction with compatible connected sensor devices that track medication adherence and for some, technique.
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Questionnaire - 5 scores
Asthma Control Questionnaire - 5 has 5 questions each ranging from a low of 0 to a high of 6. 0 indicates "never" and 6 indicates "always". The minimum mean score is a 0 and the highest mean score is a 6. The lower the score the better the outcome.
Change in normal distribution and mean Asthma Control Questionnaire - 5 scores from baseline to 6 months, which is the end of the study.
Measured: 6 months
Secondary outcomes (3)
Mini-Asthma Quality of Life Questionnaire
Mini-Asthma Quality of Life Questionnaire has 15 questions each ranging from a low of 1 to a high of 7. 1 indicates "all the time" and 7 indicates "none of the time". The higher the mean score the better the outcome.
Change in normal distribution and mean values of Mini-Asthma Quality of Life Questionnaire scores from baseline to 6-months, which is the end of study.
Measured: 6 months
Daily controller medication adherence
Daily controller medication adherence reported in the Respi.me app (registered as a percentage calculated by number of control doses taken by the participant in relation to the number of scheduled doses)
Measured: 6 months
Step up to asthma-related biologics
Asthma related biologics (step-up from inhaled corticosteroids (ICS) to biologics) scripts and use and associated cost (will be based on biologic utilization for the same type of population noted in published evidence) for those patients who have FeNO ≥ 35 ppb
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 posted15 Apr 2024
- Study start18 Jul 2024
- Primary completion27 Jan 2026
- Study completion27 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Asthma ChronicStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoheroHealth
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aptar Digital Health, Lindus Health
- Responsible party
- Sponsor
- Investigators
- David J Jackson, MRCP MSc PhD, Principal investigator, Consultant in Asthma & Eosinophilic Lung Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364527
- Sponsor's protocol ID
- ADH-BSA-02-23
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2024
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, SAP, ICF, CSR, and all data analyses will be shared by Aptar Digital Health and Lindus Health (our CRO) with the Guy's and St. Thomas' Hospital Severe Asthma Clinical team. This trial has already been approved by the local Research \& Ethics Committee.
Publications
Barry LE, O'Neill C, Butler C, Chaudhuri R, Heaney LG. Cost-Effectiveness of Fractional Exhaled Nitric Oxide Suppression Testing as an Adherence Screening Tool Among Patients With Difficult-to-Control Asthma. J Allergy Clin Immunol Pract. 2023 Jun;11(6):1796-1804.e3. doi: 10.1016/j.jaip.2023.03.008. Epub 2023 Mar 20.
PubMed 36940864Boinet T, Leroy-David C. [Asthma in adults]. Actual Pharm. 2021 Feb;60(603):13-17. doi: 10.1016/j.actpha.2020.12.008. Epub 2021 Feb 22. French.
PubMed 33642669Nordon C, Grimaldi-Bensouda L, Pribil C, Nachbaur G, Amzal B, Thabut G, Marthan R, Aubier M; COBRA Study Group. Clinical and economic burden of severe asthma: A French cohort study. Respir Med. 2018 Nov;144:42-49. doi: 10.1016/j.rmed.2018.10.002. Epub 2018 Oct 2.
PubMed 30366583Budhathoki P, Shrestha DB, Rawal E, Khadka S. Corticosteroids in COVID-19: Is it Rational? A Systematic Review and Meta-Analysis. SN Compr Clin Med. 2020;2(12):2600-2620. doi: 10.1007/s42399-020-00515-6. Epub 2020 Oct 19.
PubMed 33103063George M, Bender B. New insights to improve treatment adherence in asthma and COPD. Patient Prefer Adherence. 2019 Jul 31;13:1325-1334. doi: 10.2147/PPA.S209532. eCollection 2019.
PubMed 31534319Busse WW, Kraft M. Current unmet needs and potential solutions to uncontrolled asthma. Eur Respir Rev. 2022 Jan 25;31(163):210176. doi: 10.1183/16000617.0176-2021. Print 2022 Mar 31.
PubMed 35082128McDonald VM, Yorke J. Adherence in severe asthma: time to get it right. Eur Respir J. 2017 Dec 21;50(6):1702191. doi: 10.1183/13993003.02191-2017. Print 2017 Dec. No abstract available.
PubMed 29269587Barnes CB, Ulrik CS. Asthma and adherence to inhaled corticosteroids: current status and future perspectives. Respir Care. 2015 Mar;60(3):455-68. doi: 10.4187/respcare.03200. Epub 2014 Aug 12.
PubMed 25118311Jackson DJ, Busby J, Pfeffer PE, Menzies-Gow A, Brown T, Gore R, Doherty M, Mansur AH, Message S, Niven R, Patel M, Heaney LG; UK Severe Asthma Registry. Characterisation of patients with severe asthma in the UK Severe Asthma Registry in the biologic era. Thorax. 2021 Mar;76(3):220-227. doi: 10.1136/thoraxjnl-2020-215168. Epub 2020 Dec 9.
PubMed 33298582Blakey JD, Bender BG, Dima AL, Weinman J, Safioti G, Costello RW. Digital technologies and adherence in respiratory diseases: the road ahead. Eur Respir J. 2018 Nov 22;52(5):1801147. doi: 10.1183/13993003.01147-2018. Print 2018 Nov.
PubMed 30409819Merchant R, Szefler SJ, Bender BG, Tuffli M, Barrett MA, Gondalia R, Kaye L, Van Sickle D, Stempel DA. Impact of a digital health intervention on asthma resource utilization. World Allergy Organ J. 2018 Dec 3;11(1):28. doi: 10.1186/s40413-018-0209-0. eCollection 2018.
PubMed 30524644Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
PubMed 35691614Lara M, Edelen MO, Eberhart NK, Stucky BD, Sherbourne CD. Development and validation of the RAND Asthma Control Measure. Eur Respir J. 2014 Nov;44(5):1243-52. doi: 10.1183/09031936.00051614. Epub 2014 Jul 17.
PubMed 25034567Sherbourne CD, Stucky BD, Edelen MO, Eberhart NK, Kleerup E, Lara M. Assessing the validity of the RAND negative impact of asthma on quality of life short forms. J Allergy Clin Immunol. 2014 Oct;134(4):900-7. doi: 10.1016/j.jaci.2014.03.002. Epub 2014 Apr 18.
PubMed 24746752Rudin RS, Fanta CH, Qureshi N, Duffy E, Edelen MO, Dalal AK, Bates DW. A Clinically Integrated mHealth App and Practice Model for Collecting Patient-Reported Outcomes between Visits for Asthma Patients: Implementation and Feasibility. Appl Clin Inform. 2019 Oct;10(5):783-793. doi: 10.1055/s-0039-1697597. Epub 2019 Oct 16.
PubMed 31618782
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma: A Pilot Study
- ClinicalTrials.gov ID
- NCT06364527
- Acronym / sponsor ID
- ADH-BSA-02-23
- Conditions
- Asthma Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- CoheroHealthIndustry (pharma, biotech, devices)
- Collaborators
- Aptar Digital Health, Lindus Health
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 27 Jan 2026 (actual)
- First posted
- 15 Apr 2024 (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.
The United Kingdom has a high prevalence of asthma (over 12%) and some of the worst health outcomes in Europe. The management of respiratory disease and associated patient outcomes has long been an area of focus and improvement for the National Health Service. With the advancement of digital health technology, there is the potential to transform patient care and improve outcomes.
The Aptar Digital Health respiratory disease management platform, a digital therapeutic will be utilized to determine its value and how it supports: i) asthma patient engagement and facilitates communication between patients and providers to accelerate medication adherence; ii) asthma control through the use of the Asthma Control Questionnaire-5. In addition, spirometry and fractioned exhaled nitric oxide will be utilized during the study to validate and enhance current National Institute for Health and Care Excellence guidelines.
Detailed description
This is an open-label, single comparative study that will accrue a total of 118 participants and compare pre and post study results. Group # 1 will consist of 59 participants with a fractioned exhaled nitric oxide ≥ 45 ppb and ≥ 3 exacerbations / year (biologic eligible). Group # 2 will consist of 59 participants with a fractioned exhaled nitric oxide ≥ 45 ppb and < 3 exacerbations / year (non-biologic eligible). At the baseline visit, clinic appointment # 1, health care providers will review the participants' medical records to determine clinical outcomes in the past year, including number of exacerbations, medication pharmacy refill percentage, and fractioned exhaled nitric oxide score. At the baseline visit, participants will also complete the Asthma Control Questionnaire-5 and the Mini-Asthma Quality of Life Questionnaire. The past year clinical evaluation and Asthma Control Questionnaire-5 and Mini-Asthma Quality of Life Questionnaire will be considered baseline results.
Patients will be screened for study appropriateness at the Guy's Hospital Severe Asthma Clinic. During the initial visit, which will be considered the study baseline visit, patients will be provided with the Aptar Digital Health respiratory disease management platform and trained to use the platform. Participants will be scheduled for in person follow-up visits at 1-2 months and then 6-months post-baseline; patients will be scheduled for virtual visits at 3-months post-baseline.
Patients will then be trained by Guy's Hospital team members; Aptar Digital Health staff will provide extensive training to the Guy's Hospital team prior to the study to ensure the team is fully knowledgeable about the product, its features, and can successfully onboard participants onto the Aptar Digital Health respiratory disease management platform. Once participants are trained, they will utilize the BreatheSmart mobile application by downloading it through either the Apple Store™ or Google Play™.
The BreatheSmart mobile application records, stores, and transmits usage events to the HeroTracker sensors, or via manual user entry, to a remote storage system. Participants may self-enter their medication schedule either with or without the help of their health care providers. Through the BreatheSmart mobile application, they can review information collected from the HeroTracker Sense metered dose inhaler and FindAir ONE dry powder inhaler sensors, report and review their adherence and self-reported symptoms, and answer validated questionnaires.
Participants can share the data entered through the BreatheSmart mobile application with caregivers and health care providers. Health care providers are then able to utilize BreatheSmart Connect, a web application, to obtain an overview of all participants utilizing the Aptar Digital Health respiratory disease management platform including detailed views of individual participant information. Health care providers can view real-time adherence, medication list, participants within and outside of risk zones (depending on adherence), rescue medication usage, symptoms, and triggers. Based on the information gleaned from the BreatheSmart Connect platform, clinicians will schedule follow-up participant appointments with either a junior or senior pharmacist at the Guy's Hospital Severe Asthma Clinic.
Participants will use the Aptar Digital Health respiratory disease management platform for 6 months and will be required to return the device upon study completion.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Age < 16 years
- FeNO < 35 ppb
- Known or suspected alcohol or drug abuse which in opinion of investigator could interfere with subject's proper completion of the protocol requirement
- History of life-threatening asthma: Defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within last 6 months
- A lower respiratory tract infection within 7 days of the screening visit ● Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other respiratory disorders including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
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 |
|---|---|---|
| Aptar Digital Health respiratory disease management platformThe Aptar Digital Health respiratory disease management platform is a digital health tool that combines a Healthcare Professional portal (BreatheSmart Connect) and an associated patient mobile application (BreatheSmart mobile application). The Aptar Digital Health respiratory disease management platform is intended to be used in conjunction with compatible connected sensor devices that track medication adherence and for some, technique. | Device | – |
Primary outcome
Asthma Control Questionnaire - 5 scores
Time frame: 6 months
Asthma Control Questionnaire - 5 has 5 questions each ranging from a low of 0 to a high of 6. 0 indicates "never" and 6 indicates "always". The minimum mean score is a 0 and the highest mean score is a 6. The lower the score the better the outcome. Change in normal distribution and mean Asthma Control Questionnaire - 5 scores from baseline to 6 months, which is the end of the study.
3 secondary outcomes
Mini-Asthma Quality of Life Questionnaire
Time frame: 6 months
Daily controller medication adherence
Time frame: 6 months
Step up to asthma-related biologics
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 36940864Barry LE, O'Neill C, Butler C, Chaudhuri R, Heaney LG. Cost-Effectiveness of Fractional Exhaled Nitric Oxide Suppression Testing as an Adherence Screening Tool Among Patients With Difficult-to-Control Asthma. J Allergy Clin Immunol Pract. 2023 Jun;11(6):1796-1804.e3. doi: 10.1016/j.jaip.2023.03.008. Epub 2023 Mar 20.
- Results publication: PubMed 33642669Boinet T, Leroy-David C. [Asthma in adults]. Actual Pharm. 2021 Feb;60(603):13-17. doi: 10.1016/j.actpha.2020.12.008. Epub 2021 Feb 22. French.
- Results publication: PubMed 30366583Nordon C, Grimaldi-Bensouda L, Pribil C, Nachbaur G, Amzal B, Thabut G, Marthan R, Aubier M; COBRA Study Group. Clinical and economic burden of severe asthma: A French cohort study. Respir Med. 2018 Nov;144:42-49. doi: 10.1016/j.rmed.2018.10.002. Epub 2018 Oct 2.
- Results publication: PubMed 33103063Budhathoki P, Shrestha DB, Rawal E, Khadka S. Corticosteroids in COVID-19: Is it Rational? A Systematic Review and Meta-Analysis. SN Compr Clin Med. 2020;2(12):2600-2620. doi: 10.1007/s42399-020-00515-6. Epub 2020 Oct 19.
- Results publication: PubMed 31534319George M, Bender B. New insights to improve treatment adherence in asthma and COPD. Patient Prefer Adherence. 2019 Jul 31;13:1325-1334. doi: 10.2147/PPA.S209532. eCollection 2019.
- Results publication: PubMed 35082128Busse WW, Kraft M. Current unmet needs and potential solutions to uncontrolled asthma. Eur Respir Rev. 2022 Jan 25;31(163):210176. doi: 10.1183/16000617.0176-2021. Print 2022 Mar 31.
- Results publication: PubMed 29269587McDonald VM, Yorke J. Adherence in severe asthma: time to get it right. Eur Respir J. 2017 Dec 21;50(6):1702191. doi: 10.1183/13993003.02191-2017. Print 2017 Dec. No abstract available.
- Results publication: PubMed 25118311Barnes CB, Ulrik CS. Asthma and adherence to inhaled corticosteroids: current status and future perspectives. Respir Care. 2015 Mar;60(3):455-68. doi: 10.4187/respcare.03200. Epub 2014 Aug 12.
- Results publication: PubMed 33298582Jackson DJ, Busby J, Pfeffer PE, Menzies-Gow A, Brown T, Gore R, Doherty M, Mansur AH, Message S, Niven R, Patel M, Heaney LG; UK Severe Asthma Registry. Characterisation of patients with severe asthma in the UK Severe Asthma Registry in the biologic era. Thorax. 2021 Mar;76(3):220-227. doi: 10.1136/thoraxjnl-2020-215168. Epub 2020 Dec 9.
- Results publication: PubMed 30409819Blakey JD, Bender BG, Dima AL, Weinman J, Safioti G, Costello RW. Digital technologies and adherence in respiratory diseases: the road ahead. Eur Respir J. 2018 Nov 22;52(5):1801147. doi: 10.1183/13993003.01147-2018. Print 2018 Nov.
- Results publication: PubMed 30524644Merchant R, Szefler SJ, Bender BG, Tuffli M, Barrett MA, Gondalia R, Kaye L, Van Sickle D, Stempel DA. Impact of a digital health intervention on asthma resource utilization. World Allergy Organ J. 2018 Dec 3;11(1):28. doi: 10.1186/s40413-018-0209-0. eCollection 2018.
- Results publication: PubMed 35691614Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, 2022.Link provided by the sponsor.
- World Health Organization (WHO). Asthma. 12 May 2022.Link provided by the sponsor.
- American Academy of Pediatrics. (2022). Mild, moderate, severe asthma: what do grades mean?Link provided by the sponsor.
- NICE. Asthma: diagnosis, monitoring, and chronic asthma management. NICE guideline NG80. March 22, 2021.Link provided by the sponsor.
- NICE. Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence. NICE guidance CG76. January 28, 2009.Link provided by the sponsor.
- NICE. Measuring fractional exhaled nitric oxide concentration in asthma: NIOX MINO, NIOX VERO, and NObreath. NICE guidance DG12. April 2, 2014.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study protocol, SAP, ICF, CSR, and all data analyses will be shared by Aptar Digital Health and Lindus Health (our CRO) with the Guy's and St. Thomas' Hospital Severe Asthma Clinical team. This trial has already been approved by the local Research \& Ethics Committee.
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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. This study is not recruiting at the moment.
David J Jackson, MRCP MSc PhD principal investigator
Consultant in Asthma & Eosinophilic Lung Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aptar Digital Health respiratory disease management platform in people with Asthma Chronic, run by CoheroHealth 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 0 inclusion and 9 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: finished, as of the sponsor's last update on 24 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Questionnaire - 5 scores (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06364527, which also lists 15 linked publications.
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 24 Mar 2026.