Aptar Pilot Study v4.0
Research type
Research Study
Full title
Use of Aptar Digital Health’s respiratory platform for asthma: A pilot study
IRAS ID
335684
Contact name
David Jackson
Contact email
Sponsor organisation
Aptar Digital Health, LLC
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Asthma is a common, long-term respiratory disease that causes the air passages in the lung to become narrow due to inflammation and tightening of the muscles around the small airways causing symptoms such as a cough, wheezing, shortness of breath and chest tightness. It may alter a patient’s quality of life by causing sleep disturbance, tiredness, and poor concentration. Patients with asthma don’t always take their asthma medication properly, due to the challenges of taking an inhaled therapy. Digital therapeutics (DTx) are treatment methods based on digital technology and may be a promising solution to overcome barriers of taking asthma medication. The DTx (ADH respiratory platform) in this study combines remote monitoring, behaviour change, and personalized treatment to improve health outcomes. The ADH platform also allows patients to communicate directly with their health care providers via secure text and video calls. These solutions improve patient engagement, which may lead to improved medication adherence, clinical outcomes and decreased healthcare utilisation/associated cost. We plan to use the ADH platform to understand how it may impact the participants asthma control, quality of life, rescue medication usage, and inhaled corticosteroid (ICS) adherence.
Adult patients diagnosed with severe asthma or asthma that’s difficult to treat/uncontrolled and using inhaled medication will be recruited from either Guy’s Hospital A/E unit or Severe Asthma Clinic. Eligible participants will be scheduled for a baseline visit at the Severe Asthma Clinic. During this initial visit, consented patients will be provided with and trained on the ADH respiratory platform. At home, participants will use the ADH platform to record their medication usage and quality of life. Participants will be scheduled for follow-up visits at the Severe Asthma Clinic at 1-2 months and 6-months; a remote visit will be scheduled at 3-months. Study duration for each participant is 6 months.REC name
Wales REC 1
REC reference
23/WA/0325
Date of REC Opinion
20 Dec 2023
REC opinion
Further Information Favourable Opinion