Digital health platform for managing asthma
Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma: A Pilot Study
This study tests a digital health platform to see if it can help people with asthma better manage their condition and communicate with their doctors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | CoheroHealth Industry-sponsored |
| Drugs / interventions | omalizumab, mepolizumab |
| Locations | 1 site (London, England) |
| Trial ID | NCT06364527 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Aptar Digital Health respiratory disease management platform to improve asthma patient engagement and communication between patients and healthcare providers. It aims to enhance medication adherence and asthma control using the Asthma Control Questionnaire-5, alongside spirometry and fractioned exhaled nitric oxide measurements. The study will involve 118 participants divided into two groups based on their exacerbation history and will include both in-person and virtual follow-up visits to assess outcomes over time.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 and older with uncontrolled, moderate-to-severe asthma who are using asthma controller therapy.
Not a fit: Patients with well-controlled asthma or those not using asthma controller therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve asthma management and patient outcomes through enhanced engagement and adherence.
How similar studies have performed: Other studies utilizing digital health technologies for asthma management have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
London, England
- Guy's and St. Thomas' NHS Foundation Trust — London, England, United Kingdom (Recruiting)
Study contacts
- Principal investigator: David J Jackson, MRCP MSc PhD — Consultant in Asthma & Eosinophilic Lung Diseases
- Study coordinator: Akash Bijlani, MPH
- Email: akash.bijlani@aptar.com
- Phone: 6502489166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.