NCT06364527Completed
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
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 94 (actual)
- First submitted
- 27 Mar 2024
- Start date
- 18 Jul 2024
- Primary completion date
- 27 Jan 2026
- Lead sponsor
- CoheroHealth
- Diseases
- Asthma
- NCT number
- NCT06364527
What you commit to
- Study type: Interventional
- Participants enrolled: 94
- From 18 Jul 2024 to the primary completion date, 27 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known or suspected alcohol or drug abuse which in opinion of investigator could interfere with subject's proper completion of the protocol requirement
- 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.
- 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
Other illness
- 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
Lab values
- 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.
Age
- Age \< 16 years
Other
- FeNO \< 35 ppb
- 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.
Criteria the registry did not label
- 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
Age in the registry: 16 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guy's and St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.