Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma

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.

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.

• 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 controller medications is noted in section 9.2.
• FeNO ≥ 35 ppb during the baseline assessment.
• Primary respiratory diagnosis of asthma
• Uncontrolled, moderate-to-severe asthma. This is defined by an ACQ-5 ≥1.5 during the baseline assessment.
• Current non-smoker. A 'current non-smoker' has never smoked or has quit smoking for at least 12 months. This is inclusive of all types of smoking: i.e. e-cigarettes/vaping.
• 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: ≥ 11 or iOS: ≥ 15)
• Ability to use smartphone (smartphone usability assessment to be provided by Aptar Digital Health)
• Access to the UK app store or google play store for application download. ● Access to a current email account
• Access to data / Wi-Fi

Exclusion Criteria

• 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.
• 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.