Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma
NCT ID: NCT06364527
Last Updated: 2024-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
118 participants
INTERVENTIONAL
2024-07-18
2025-11-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Participants with fractioned exhaled nitric oxide ≥ 45 ppb
Group 1 consists of 59 participants with a fractioned exhaled nitric oxide ≥ 45 ppb and ≥ 3 exacerbations / year (biologic eligible). Group 2 consists of 59 participants with a fractioned exhaled nitric oxide ≥ 45 ppb and \< 3 exacerbations / year (biologic ineligible).
Aptar Digital Health respiratory disease management platform
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.
Interventions
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Aptar Digital Health respiratory disease management platform
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.
Eligibility Criteria
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Inclusion Criteria
* Utilization of asthma controller therapy: inhaled corticosteroids (ICS), long-acting β2-agonists (LABAs) and/or fixed combination therapies of LABA and ICS (medium to high-dose ICS/LABA therapy)
* Use of metered dose inhaler (MDI) and / or dry powder dose inhaler (DPI) list of compatible medications is noted in section 9.2.
* FeNO ≥ 45 ppb
* Primary respiratory diagnosis of asthma
* Patients with uncontrolled, moderate-to-severe asthma
* Non-smoker
* Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in consent form and protocol.
* Subject understands and is willing, able, and likely to comply with study procedures and restrictions
* Willingness to participate in this study and to use the Aptar Digital Health technology
* Willingness to share information / data with Aptar Digital Health (through informed consent)
Access to technology
* Access to a smartphone (requirements Android ≥13 and iOS ≥16
* Ability to use smartphone (smartphone usability assessment to be provided by Aptar Digital Health)
* Access to a current email account
* Access to data / Wi-Fi
Exclusion Criteria
* FeNO \< 45 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 hypercapnia, 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.
* 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.
16 Years
ALL
Yes
Sponsors
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Aptar Digital Health
INDUSTRY
Lindus Health
INDUSTRY
CoheroHealth
INDUSTRY
Responsible Party
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Principal Investigators
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David J Jackson, MRCP MSc PhD
Role: PRINCIPAL_INVESTIGATOR
Consultant in Asthma & Eosinophilic Lung Diseases
Locations
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Guy's and St. Thomas' NHS Foundation Trust
London, England, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Boinet 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.
Nordon 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.
Budhathoki 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.
George 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.
Busse 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.
McDonald 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.
Barnes 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.
Jackson 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.
Blakey 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.
Merchant 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.
Chan 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.
Lara 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.
Sherbourne 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.
Rudin 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.
Related Links
Access external resources that provide additional context or updates about the study.
Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, 2022.
World Health Organization (WHO). Asthma. 12 May 2022.
American Academy of Pediatrics. (2022). Mild, moderate, severe asthma: what do grades mean?
Pharmaceutical Services Negotiating Committee (PSNC). Essential facts, stats, and quotes relating to asthma. March 28, 2022.
NICE. Asthma: diagnosis, monitoring, and chronic asthma management. NICE guideline NG80. March 22, 2021.
NICE. Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence. NICE guidance CG76. January 28, 2009.
NICE. Measuring fractional exhaled nitric oxide concentration in asthma: NIOX MINO, NIOX VERO, and NObreath. NICE guidance DG12. April 2, 2014.
Oxford Academic Health Science Network. Consensus pathway for management of uncontrolled asthma in adults. June 2022.
Other Identifiers
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ADH-BSA-02-23
Identifier Type: -
Identifier Source: org_study_id
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