Asthma COPDVAL-HEPHAINCT06099145
Clinical and Medico-economic Validation of the HEPHAI Solution.
A study testing Hephaï in people with Asthma COPD, run by Hephai at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma COPD
- What is being tested?
- Hephaï
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 5 sitesFrance
- Study dates
- 19 Sep 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Not yet recruiting
CHU de Dijon
Dijon, 21079
Philippe Bonnaud, Prof.
- Not yet recruiting
Hôpital Arnaud de Villeneuve
Montpellier, 34090
- Recruiting
Pitié-Salpêtrière Hospital
Paris, 75011
Capucine Morélot-Panzini, Prof.
- Not yet recruiting
Hôpital COCHIN
Paris, 75014
Nicolas Roche, Prof.
- Recruiting
Hôpital BICHAT
Paris, 75018
Camille Taille, Prof.
About this study
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
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
Read the 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.
- Conditions
- Asthma COPD
- Being tested
- Hephaï
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HephaïDevice
Used of the HEPHAI medical device as a tool to improve the delivery of inhaled treatments for asthma and COPD
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Patient who received inhaled treatment with Innovair® or Trimbow® as a part standard care for 6 months |
| Hephai | Experimental | Patient using the Hephaï medical device as a tool who received inhaled treatment with Innovair® or Trimbow® as a part standard care for 6 months Receives: Device: Hephaï |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Critical Errors at week 12
Assessment of the proportion of critical errors during inhaler use, from baseline to 3 months after initiation of the intervention.
A critical error is defined as an error during use of the device that would compromise access of the inhaled medication to the respiratory tract, The methodology used to assess critical errors consists in comparing the results of the investigating physician's observation of use with a reference checklist developed on the basis of official recommendations for use.
Measured: Baseline and week 12
Secondary outcomes (3)
Proportion of Critical Errors at week 24
Assessment of the proportion of critical errors during inhaler use, from baseline to 6 months after initiation of the intervention.
A critical error is defined as an error during use of the device that would compromise access of the inhaled medication to the respiratory tract, The methodology used to assess critical errors consists in comparing the results of the investigating physician's observation of use with a reference checklist developed on the basis of official recommendations for use.
Measured: Baseline to week 24
Quality of Life Assessment (Saint-Georges' Hospital Questionnaire)
Assessment of quality of life using the Saint-Georges' Hospital questionnaire (French version) at each time, with a specific focus on the evolution from baseline to week 24
Measured: Baseline to week 24
Quality of Life Assessment (EQ5D5L Questionnaire)
Assessment of quality of life using the EQ5D5L questionnaire at each time, with a specific focus on the evolution from baseline to week 24
Measured: Baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start19 Sep 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an interventional, multicenter, randomized, controlled clinical study.
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hephai
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Capucine Capucine.morelot@aphp.fr, Prof., Principal investigator, Department of Pneumonology, Pitié-Salpêtrière Hospital,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099145
- Sponsor's protocol ID
- KM00385
- Acronym
- VAL-HEPHAI
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06099145
- Acronym / sponsor ID
- VAL-HEPHAI / KM00385
- Conditions
- Asthma COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- HephaiIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an interventional, multicenter, randomized, controlled clinical study.
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Patient who received inhaled treatment with Innovair® or Trimbow® as a part standard care for 6 months |
| Hephai | Experimental | Device: HephaïPatient using the Hephaï medical device as a tool who received inhaled treatment with Innovair® or Trimbow® as a part standard care for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HephaïUsed of the HEPHAI medical device as a tool to improve the delivery of inhaled treatments for asthma and COPD | Device | Hephai |
Primary outcome
Proportion of Critical Errors at week 12
Time frame: Baseline and week 12
Assessment of the proportion of critical errors during inhaler use, from baseline to 3 months after initiation of the intervention. A critical error is defined as an error during use of the device that would compromise access of the inhaled medication to the respiratory tract, The methodology used to assess critical errors consists in comparing the results of the investigating physician's observation of use with a reference checklist developed on the basis of official recommendations for use.
3 secondary outcomes
Proportion of Critical Errors at week 24
Time frame: Baseline to week 24
Quality of Life Assessment (Saint-Georges' Hospital Questionnaire)
Time frame: Baseline to week 24
Quality of Life Assessment (EQ5D5L Questionnaire)
Time frame: Baseline to week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Capucine Capucine.morelot@aphp.fr, Prof. principal investigator
Department of Pneumonology, Pitié-Salpêtrière Hospital,
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hephaï in people with Asthma COPD, run by Hephai at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serge Kinkingnehun (+33 6 61 85 06 77, serge@hephai.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Critical Errors at week 12 (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.