Clinical trial NCT06364527: Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma
Official title: Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma Chronic
Lead sponsor: CoheroHealth
Sponsor class: INDUSTRY
Collaborators: name: Aptar Digital Health
name: Lindus Health
First posted: 2024-04-15
Enrollment: 118
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 16 years
* 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:

* Age \< 16 years
* 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.

Primary outcomes:
measure: Asthma Control Questionnaire - 5 scores
timeFrame: 6 months
Secondary outcomes:
measure: Mini-Asthma Quality of Life Questionnaire
timeFrame: 6 months
measure: Rescue medication usage
timeFrame: 6 months
measure: Inhaled corticosteroid steroid daily adherence
timeFrame: 6 months
Other outcomes:
measure: Step-up from inhaled corticosteroids to biologics
timeFrame: 6 months
measure: Asthma related oral corticosteroids utilization and associated cost
timeFrame: 6 months
measure: Asthma related accident and emergency department visits and associated cost
timeFrame: 6 months
measure: Asthma related unscheduled outpatient clinic visits and associated cost
timeFrame: 6 months
measure: Asthma related inpatient hospitalization, associated length of stay, and associated cost
timeFrame: 6 months
measure: Computer System Usability Questionnaire
timeFrame: 6 months
measure: Semi-structured interviews using the 2019 Rudin et al study
timeFrame: 6 months
Locations:
city: London
country: United Kingdom
facility: Guy's and St. Thomas' NHS Foundation Trust
state: England
Study officials:
affiliation: Consultant in Asthma & Eosinophilic Lung Diseases
name: David J Jackson, MRCP MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.