Improving inhaler use for asthma and COPD patients with HEPHAÏ

Clinical and Medico-economic Study to Validate the Performance of a Digital and Personalized Solution (HEPHAÏ) to Support the Use of Inhaled Treatments for Asthma and COPD

This study is testing an app that helps asthma and COPD patients use their inhalers correctly by giving them real-time feedback on their technique.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 238 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hephai (Industry-sponsored)
• Locations: 5 sites (Dijon and 4 other locations)
• Trial ID: NCT06099145 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the HEPHAÏ solution, an AI-based application designed to enhance the proper use of inhalation devices among patients with asthma and COPD. By allowing patients to film their inhaler usage, the app analyzes their technique in real-time, providing immediate feedback and corrective guidance if errors are detected. The study aims to reduce the frequency of critical errors associated with inhaler use, which can lead to ineffective treatment and increased healthcare costs. The HEPHAÏ solution is intended to be a supportive tool for patients using Innovair® or Trimbow® inhalers.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with asthma or COPD who are using Innovair® or Trimbow® inhalers and have access to the necessary technology.

Not a fit: Patients with sensory impairments or cognitive limitations that hinder their ability to use the HEPHAÏ application may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment effectiveness and reduce healthcare costs associated with asthma and COPD exacerbations.

How similar studies have performed: While the use of AI in healthcare is growing, this specific application for inhaler use is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

* Patient at least 18 years of age
* Patient followed in pulmonology for Asthma and/or COPD with implementation and/or follow-up of treatment with Innovair® or Trimbow®,
* Patient affiliated to a Social Security scheme,
* Patient with a hardware support allowing the operation of HEPHAÏ: smartphone, tablet, desktop or laptop computer with graphical interface, video, sound and a high-speed connection at the place of use.

Exclusion Criteria:

* Patient previously enrolled in another interventional clinical study,
* Adult patients who are subject to a legal protection measure (guardianship, judicial safeguard, psychiatric care or deprived of liberty by judicial or administrative decision),
* Patient with at least one sensory, visual or tactile impairment, preventing the correct use of a smartphone, tablet and/or computer or preventing the correct performance of the exercise safely,
* Patient with a cognitive impairment, severely limiting their ability to concentrate and thus preventing the correct use of a smartphone, tablet and/or computer,
* Patient cared for by a specialized team of education, therapeutic for his asthma or COPD follow-up (e.g. asthma school, asthma referent IDE),
* Patient who does not understand French,
* Patient with an inhalation chamber prescription associated with their inhalation device prescription.

Where this trial is running

Dijon and 4 other locations

• CHU de Dijon — Dijon, France (Not_yet_recruiting)
• Hôpital Arnaud de Villeneuve — Montpellier, France (Not_yet_recruiting)
• Pitié-Salpêtrière Hospital — Paris, France (Recruiting)
• Hôpital COCHIN — Paris, France (Not_yet_recruiting)
• Hôpital BICHAT — Paris, France (Recruiting)

Study contacts

• Principal investigator: Capucine [e-mail], Prof. — Department of Pneumonology, Pitié-Salpêtrière Hospital,
• Study coordinator: Serge Kinkingnehun

Conditions Asthma COPD