Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma: A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
United Kingdom
Guy's and St. Thomas' NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Akash Bijlani, MPH
akash.bijlani@aptar.com
6502489166
Backup
Amy Moore
amy@lindushealth.com
073 559 82296
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2025-11
Participants
Target number of participants: 118
Treatments
Experimental: 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).
Related Therapeutic Areas
Sponsors
Leads: CoheroHealth
Collaborators: Aptar Digital Health, Lindus Health

This content was sourced from clinicaltrials.gov