Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma (NCT06364527) | Clinical Trial Compass
CompletedNot Applicable
Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma
United Kingdom94 participantsStarted 2024-07-18
Plain-language 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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.