Clinical trial NCT06099145: Clinical and Medico-economic Validation of the HEPHAI Solution.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma COPD
Lead sponsor: Hephai
Sponsor class: INDUSTRY
First posted: 2023-10-25
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an interventional, multicenter, randomized, controlled clinical study.
Primary purpose: OTHER

Brief summary: In a context where the use of inhalation devices for respiratory medications is associated with a high frequency of critical errors, our primary hypothesis is that the use of the HEPHAÏ solution reduces this frequency compared to standard care.

The objective of this clinical study is to evaluate the performance of the HEPHAÏ solution as a tool for improving the administration of inhaled treatments in patients undergoing pulmonary care for asthma and/or COPD, who are receiving treatment with Innovair® or Trimbow®. These two inhalers were chosen for reasons of feasibility and compatibility with the version of the HEPHAÏ software provided as part of the clinical investigation

Detailed description: The proper use of inhalation devices is crucial to relieving asthma and COPD symptoms and preventing exacerbations of these diseases. The improper use of these devices is currently considered a major problem. HEPHAI (Class I Medical Device) is a versatile application based on artificial intelligence (AI), allowing to recognize the appropriate use of an inhalation device by analyzing (without any sensors either on the patient or on the inhaler), the sequence of movements and sounds necessary for error-free intake. The HEPHAI application allows the patient to film themselves directly when using their inhaler, to interrogate in real time an AI based on behavior recognition (movements and sounds), to give the patient an immediate result, and to set up a corrective process if the intake has not been properly carried out.

HEPHAÏ is thus a companion tool to the inhaler prescribed by the doctor, which allows the patient to benefit from assistance in the use of his or her personalized inhaler at home.

Among patients using an inhalation device for their treatment, 30% to 40% make errors of use that are considered "critical", i.e. making the treatment ineffective or drastically reducing its effectiveness. Beyond its clinical impact (persistence of symptoms, decreased adherence, increased risk of exacerbation), the economic cost of this inadequate use is estimated at nearly one billion euros per year in France, with a major weight of hospitalizations for exacerbations.

In this contaxt, the objective of the present study is to evaluate the performance of the HEPHAÏ solution as a tool for improving the administration of inhaled treatments in patients undergoing pulmonary care for asthma and/or COPD.

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.

Primary outcomes:
measure: Proportion of Critical Errors at week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Proportion of Critical Errors at week 24
timeFrame: Baseline to week 24
measure: Quality of Life Assessment (Saint-Georges' Hospital Questionnaire)
timeFrame: Baseline to week 24
measure: Quality of Life Assessment (EQ5D5L Questionnaire)
timeFrame: Baseline to week 24
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
city: Paris
country: France
facility: Pitié-Salpêtrière Hospital
city: Paris
country: France
facility: Hôpital COCHIN
city: Paris
country: France
facility: Hôpital BICHAT
Study officials:
affiliation: Department of Pneumonology, Pitié-Salpêtrière Hospital,
name: Capucine Capucine.morelot@aphp.fr, Prof.
role: PRINCIPAL_INVESTIGATOR
References: