Amyotrophic Lateral Sclerosis ALS7PEPINEXNCT06249412
The Importance of Positive Expiratory Pressure Associated With the In-exsufflator in ALS Patients
A study testing MI-E with PEP function activated during the pause and MI-E without PEP function activated during the pause in people with Amyotrophic Lateral Sclerosis ALS7, run by Groupe Hospitalier du Havre at 1 site in France.
Trial summary
Amyotrophic Lateral Sclerosis (ALS) is a fatal neurodegenerative disorder that impairs motor neurons, with a life expectancy of 2 to 7 years after diagnosis. ALS manifests as 'spinal' when it primarily affects limbs, or 'bulbar' when it impairs speech and swallowing. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis ALS7
- What is being tested?
- MI-E with PEP function activated during the pause and MI-E without PEP function activated during the pause
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient aged over 18 years
- Patient with Amyotrophic Lateral Sclerosis (ALS)
- Patients with established or beginning bulbar disorders, identified by the healthcare team (speech impairment, hypersalivation, or swallowing difficulties)
- Patient naive to INEX therapy but prescribed for its installation or patient already treated by an INEX device
- Patient followed by the ALS mobile team of the Groupe Hospitalier du Havre or the CHU of Dijon
- Patient whose disease progression kinetics is medically deemed compatible with inclusion in the study
- Patient willing to participate in the research after receiving adequate information and the information letter.
- Patient affiliated with social security or a beneficiary of such a scheme.
Who cannot join
- "● Patient not presenting an episode of infection or a past episode of respiratory infection less than one month old
- Mental illness interfering with the proper use of the device
- History of laryngospasm
- Inability to come for consultation with the ALS team of the Groupe Hospitalier du Havre or the CHU of Dijon
- Pregnancy
- Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curatorship) Article L1121-8.
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- Appearance of a non-inclusion criterion
- Refusal to participate after inclusion
- Death from any cause"
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
GH Havre
Le Havre, Normandy, 76290
COMBRET Yann, PhD, yann.combret@gmail.com
About this study
Official title: The Importance of Positive Expiratory Pressure Associated With the In-exsufflator in Patients With Amyotrophic Lateral Sclerosis on the Effectiveness of Therapy
Amyotrophic Lateral Sclerosis (ALS) is a fatal neurodegenerative disorder that impairs motor neurons, with a life expectancy of 2 to 7 years after diagnosis. ALS manifests as 'spinal' when it primarily affects limbs, or 'bulbar' when it impairs speech and swallowing. The disease progressively weakens all skeletal muscles, causing respiratory issues and increased risk of lung infections due to ineffective coughing. Mechanical cough assistance via In-exsufflation therapy/ mechanical in-exsufflator devie (INEX/MI-E) applies positive and negative airway pressures non-invasively to improve coughing. However, MI-E may fail in some ALS patients due to airway collapse, often related to brainstem muscle dysfunction.Research by Andersen et al. in 2017 highlighted that during MI-E, ALS patients often experience adverse laryngeal movements, which can obstruct airways and reduce the therapy's effectiveness. To combat this, they suggested individualized MI-E settings to minimize airway collapse. Modern MI-E devices, such as the EOVE-70, offer adjustable positive expiratory pressure (PEP) between cycles to potentially enhance airway stability and coughing efficiency. The current study focuses on the impact of PEP during therapy pauses on the peak expiratory flow rate in ALS patients, which could lead to improved therapeutic outcomes.
Read the detailed description
Amyotrophic Lateral Sclerosis (ALS) is an incurable and debilitating neurodegenerative disease affecting both upper and lower motor neurons. The average life expectancy upon diagnosis ranges from 2 to 7 years. Treatment is symptomatic, aiming to manage symptoms rather than cure the disease. ALS can be classified as 'spinal' when symptoms primarily affect the limbs or 'bulbar' when the disease manifests with speech, swallowing, or coughing difficulties. Regardless of the subtype, ALS eventually affects all skeletal muscles, including respiratory muscles, leading to impaired coughing efficiency, secretion buildup, and increased lung infections. Enhancing cough efficiency is crucial for clearing airway secretions and reducing pneumonia risk.
In healthy individuals, coughing involves an increase in lung volume by inspiratory muscles, coordination of the glottis by laryngeal muscles, and increased thoracoabdominal pressure by expiratory muscles. This process is disrupted in ALS patients. In-exsufflation therapy is widely used and recommended to assist coughing mechanically by applying non-invasive positive and negative pressure changes through a mask. For MI-E to be effective and keep the upper airways open during therapy, coordinated glottic movements are essential. The ultimate goal is to increase peak expiratory flow (PEF) during coughing. However, in some patients, MI-E is ineffective due to the collapse of the upper airways during both phases of the therapy-insufflation and exsufflation-but especially during inspiration, possibly due to dysfunction of the muscles innervated by the brainstem.
In 2017, Andersen et al. demonstrated via laryngoscopies conducted during MI-E use that the therapy was associated with:
Adduction of the supraglottic laryngeal structures during the insufflation phase.
Retraction of the tongue base into the hypopharynx during insufflation. Adduction of the vocal cords in ALS patients during both insufflation and exsufflation, regardless of subtype.
These factors compromised the therapy's effectiveness, which aims to increase PEF during cough
Andersen et al. concluded that it is important to personalize and adjust the MI-E settings to reduce the risk of airway collapse and allow the maximum number of ALS patients to benefit from it.
Today, several MI-E devices are available on the market, sharing similar settings for target pressure (positive/negative), inspiratory/expiratory time, automation, etc. Notably, one particular device (EOVE-70, Eove, Pau) offers the use and adjustment of a positive expiratory pressure (PEP) during the pause (i.e., between each delivered cycle), which could reduce the risk of airway collapse during therapy, and improve cough expiratory flow rate as well as the tolerance and effectiveness of the treatment in ALS patients.
The aim of this study is to evaluate the effect of using the positive expiratory pressure function during the pause and before the following insufflation on the peak expiratory flow rate of cough in patients with ALS during MI-E therapy
- Conditions
- Amyotrophic Lateral Sclerosis ALS7
- Being tested
- MI-E with PEP function activated during the pause, MI-E without PEP function activated during the pause
- Keywords
- ALS, Amyotrophic Lateral Sclerosis, MI-E therapy, INEX therapy, Airway clearance technics, Neuromuscular disease, Cough assit
- Medical subject headings
- Amyotrophic Lateral Sclerosis 7, Amyotrophic Lateral Sclerosis, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI-E with PEP function activated during the pauseDevice
PEP function will be activated during the pause when using the EOVE-70. The PEP function in cmH2O will start at 8 cmH2O; the PEP setting can be decreased or increased at the discretion of the practitioner to optimize. The other therapeutic settings (positive pressure, negative pressure, inspiratory time, expiratory time and pause time) will be set individually for each patient by an experienced physiotherapist in order to reach the best clinical efficacy (usual clinical care)
MI-E without PEP function activated during the pauseDevice
The PEP function will not be activated during the pause when using the EOVE-70. The other therapeutic settings (positive pressure, negative pressure, inspiratory time, expiratory time and pause time) will be set individually for each patient by an experienced physiotherapist in order to reach the best clinical efficacy (usual clinical care)
| Study group | Role | What they receive |
|---|---|---|
| MI-E with Positive expiratory pressure during pause (PEP) | Experimental | With the MI-E EOVE-70 device, it is possible to enable the setting of PEP (Positive Expiratory Pressure) during the pause. When this setting is activated, PEP can be adjusted between 1 and 20 cmH2O. The MI-E session will last, depending on patient tolerance, between 8 and 15 minutes. In this study, the MI-E will be set in automatic or semi-automatic mode with settings proposed by the physiotherapists based on the effectiveness and tolerance of the patient. To titrate PEP, the practitioner will start at 8 cmH2O; the setting can be decreased or increased at the discretion of the practitioner to optimize it, based on the inspiratory volume and peak expiratory flow (PEF) measured by the device at each cycle (usual clinical practice). The practitioner can adjust PEP between a minimum of 4 and a maximum of 15 cmH2O. A wash-out period of 30 minutes is planned between each INEX session with and without the PEP function activated (Experimental arm and comparative arm) Receives: Device: MI-E with PEP function activated during the pause |
| MI-E without Positive expiratory pressure during pause (PEP) | Active comparator | The MI-E session will last, depending on patient tolerance, between 8 and 15 minutes. In this study, the MI-E will be set in automatic or semi-automatic mode with settings proposed by the physiotherapists based on the effectiveness and tolerance of the patient. The PEP function will not be used by the practitioner (ie. 0 cmH2O of PEP during the pause). A wash-out period of 30 minutes is planned between each INEX session with and without the PEP function activated (Experimental arm and comparative arm) Receives: Device: MI-E without PEP function activated during the pause |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average difference in PEF (Peak Expiratory Flow) in L/min with the use of the PEP function and without the use of this function.
We aim to study the effect of using PEP during the pause on cough peak expiratory flow (PEF) in patients with ALS during MI-E therapy. The PEF from all treatment cycles measured by an external pneumotachograph connected to the circuit between the machine and the patient will be averaged and compared between the arms: with and without PEP during the pause
Measured: Between 5 and 15 minutes (MI-E treatment period)
Secondary outcomes (5)
The average difference in inspiratory volume in mililiters with the use of the PEP function and without the use of this function.
We aim to study the effect of using PEP during the pause on inspiratory volume delivered in patients with ALS during MI-E therapy. The inspiratory volume from all treatment cycles measured by an external pneumotachograph connected to the circuit between the machine and the patient will be averaged and compared between the arms: with and without PEP during the pause
Measured: Between 5 and 15 minutes (MI-E treatment period)
The perceived effect of PEP during pause on the effectiveness of MI-E therapy by the patient as well as their perceived comfort
We wish to measure the average difference on the VAS (Visual Analogue Scale) with the use of the PEP function and without the use of this function, for the sensation of effectiveness and comfort reported by the patient
Measured: Between 5 and 15 minutes (MI-E treatment period)
Qualitative analysis of cough using flow/time graphs of patient coughs with the use of the PEP function and without the use of this function.
We wish to measure qualitatively (visually in post-analysis) the flow/time data recorded by the external pneumotachograph with the use of the PEP function and without the use of this function.
Measured: Between 5 and 15 minutes (MI-E treatment period)
Comparison of PEF (Peak Expiratory Flow) reported by the MI-E machine versus PEF measured by the external pneumotachograph in L/min
We wish to compare the data reported by the device versus the data externaly recorded for a post-analysis comparison.
Measured: Between 5 and 15 minutes (MI-E treatment period)
Comparison of Inspiratory Volume reported by the MI-E machine versus Inspiratory Volume measured by the external pneumotachograph in mililiters
We wish to compare the data reported by the device versus the data externaly recorded for a post-analysis comparison.
Measured: Between 5 and 15 minutes (MI-E treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start19 Dec 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis ALS7Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Collaborators
- French Physiotherapy Society / Société Français de Physiothérapie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249412
- Sponsor's protocol ID
- 2023-A01269-36
- Acronym
- PEPINEX
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Positive Expiratory Pressure Associated With the In-exsufflator in Patients With Amyotrophic Lateral Sclerosis on the Effectiveness of Therapy
- ClinicalTrials.gov ID
- NCT06249412
- Acronym / sponsor ID
- PEPINEX / 2023-A01269-36
- Conditions
- Amyotrophic Lateral Sclerosis ALS7
- Keywords
- ALS, Amyotrophic Lateral Sclerosis, MI-E therapy, INEX therapy, Airway clearance technics, Neuromuscular disease, Cough assit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Collaborators
- French Physiotherapy Society / Société Français de Physiothérapie
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 8 Feb 2024 (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.
Amyotrophic Lateral Sclerosis (ALS) is a fatal neurodegenerative disorder that impairs motor neurons, with a life expectancy of 2 to 7 years after diagnosis. ALS manifests as 'spinal' when it primarily affects limbs, or 'bulbar' when it impairs speech and swallowing. The disease progressively weakens all skeletal muscles, causing respiratory issues and increased risk of lung infections due to ineffective coughing. Mechanical cough assistance via In-exsufflation therapy/ mechanical in-exsufflator devie (INEX/MI-E) applies positive and negative airway pressures non-invasively to improve coughing. However, MI-E may fail in some ALS patients due to airway collapse, often related to brainstem muscle dysfunction.Research by Andersen et al. in 2017 highlighted that during MI-E, ALS patients often experience adverse laryngeal movements, which can obstruct airways and reduce the therapy's effectiveness. To combat this, they suggested individualized MI-E settings to minimize airway collapse. Modern MI-E devices, such as the EOVE-70, offer adjustable positive expiratory pressure (PEP) between cycles to potentially enhance airway stability and coughing efficiency. The current study focuses on the impact of PEP during therapy pauses on the peak expiratory flow rate in ALS patients, which could lead to improved therapeutic outcomes.
Detailed description
Amyotrophic Lateral Sclerosis (ALS) is an incurable and debilitating neurodegenerative disease affecting both upper and lower motor neurons. The average life expectancy upon diagnosis ranges from 2 to 7 years. Treatment is symptomatic, aiming to manage symptoms rather than cure the disease. ALS can be classified as 'spinal' when symptoms primarily affect the limbs or 'bulbar' when the disease manifests with speech, swallowing, or coughing difficulties. Regardless of the subtype, ALS eventually affects all skeletal muscles, including respiratory muscles, leading to impaired coughing efficiency, secretion buildup, and increased lung infections. Enhancing cough efficiency is crucial for clearing airway secretions and reducing pneumonia risk.
In healthy individuals, coughing involves an increase in lung volume by inspiratory muscles, coordination of the glottis by laryngeal muscles, and increased thoracoabdominal pressure by expiratory muscles. This process is disrupted in ALS patients. In-exsufflation therapy is widely used and recommended to assist coughing mechanically by applying non-invasive positive and negative pressure changes through a mask. For MI-E to be effective and keep the upper airways open during therapy, coordinated glottic movements are essential. The ultimate goal is to increase peak expiratory flow (PEF) during coughing. However, in some patients, MI-E is ineffective due to the collapse of the upper airways during both phases of the therapy-insufflation and exsufflation-but especially during inspiration, possibly due to dysfunction of the muscles innervated by the brainstem.
In 2017, Andersen et al. demonstrated via laryngoscopies conducted during MI-E use that the therapy was associated with:
Adduction of the supraglottic laryngeal structures during the insufflation phase.
Retraction of the tongue base into the hypopharynx during insufflation. Adduction of the vocal cords in ALS patients during both insufflation and exsufflation, regardless of subtype.
These factors compromised the therapy's effectiveness, which aims to increase PEF during cough
Andersen et al. concluded that it is important to personalize and adjust the MI-E settings to reduce the risk of airway collapse and allow the maximum number of ALS patients to benefit from it.
Today, several MI-E devices are available on the market, sharing similar settings for target pressure (positive/negative), inspiratory/expiratory time, automation, etc. Notably, one particular device (EOVE-70, Eove, Pau) offers the use and adjustment of a positive expiratory pressure (PEP) during the pause (i.e., between each delivered cycle), which could reduce the risk of airway collapse during therapy, and improve cough expiratory flow rate as well as the tolerance and effectiveness of the treatment in ALS patients.
The aim of this study is to evaluate the effect of using the positive expiratory pressure function during the pause and before the following insufflation on the peak expiratory flow rate of cough in patients with ALS during MI-E therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI-E with Positive expiratory pressure during pause (PEP) | Experimental | Device: MI-E with PEP function activated during the pauseWith the MI-E EOVE-70 device, it is possible to enable the setting of PEP (Positive Expiratory Pressure) during the pause. When this setting is activated, PEP can be adjusted between 1 and 20 cmH2O. The MI-E session will last, depending on patient tolerance, between 8 and 15 minutes. In this study, the MI-E will be set in automatic or semi-automatic mode with settings proposed by the physiotherapists based on the effectiveness and tolerance of the patient. To titrate PEP, the practitioner will start at 8 cmH2O; the setting can be decreased or increased at the discretion of the practitioner to optimize it, based on the inspiratory volume and peak expiratory flow (PEF) measured by the device at each cycle (usual clinical practice). The practitioner can adjust PEP between a minimum of 4 and a maximum of 15 cmH2O. A wash-out period of 30 minutes is planned between each INEX session with and without the PEP function activated (Experimental arm and comparative arm) |
| MI-E without Positive expiratory pressure during pause (PEP) | Active comparator | Device: MI-E without PEP function activated during the pauseThe MI-E session will last, depending on patient tolerance, between 8 and 15 minutes. In this study, the MI-E will be set in automatic or semi-automatic mode with settings proposed by the physiotherapists based on the effectiveness and tolerance of the patient. The PEP function will not be used by the practitioner (ie. 0 cmH2O of PEP during the pause). A wash-out period of 30 minutes is planned between each INEX session with and without the PEP function activated (Experimental arm and comparative arm) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patient aged over 18 years
- Patient with Amyotrophic Lateral Sclerosis (ALS)
- Patients with established or beginning bulbar disorders, identified by the healthcare team (speech impairment, hypersalivation, or swallowing difficulties)
- Patient naive to INEX therapy but prescribed for its installation or patient already treated by an INEX device
- Patient followed by the ALS mobile team of the Groupe Hospitalier du Havre or the CHU of Dijon
Key exclusion criteria (9 listed)
- "● Patient not presenting an episode of infection or a past episode of respiratory infection less than one month old
- Mental illness interfering with the proper use of the device
- History of laryngospasm
- Inability to come for consultation with the ALS team of the Groupe Hospitalier du Havre or the CHU of Dijon
- Pregnancy
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 |
|---|---|---|
| MI-E with PEP function activated during the pausePEP function will be activated during the pause when using the EOVE-70. The PEP function in cmH2O will start at 8 cmH2O; the PEP setting can be decreased or increased at the discretion of the practitioner to optimize. The other therapeutic settings (positive pressure, negative pressure, inspiratory time, expiratory time and pause time) will be set individually for each patient by an experienced physiotherapist in order to reach the best clinical efficacy (usual clinical care) | Device | MI-E with Positive expiratory pressure during pause (PEP) |
| MI-E without PEP function activated during the pauseThe PEP function will not be activated during the pause when using the EOVE-70. The other therapeutic settings (positive pressure, negative pressure, inspiratory time, expiratory time and pause time) will be set individually for each patient by an experienced physiotherapist in order to reach the best clinical efficacy (usual clinical care) | Device | MI-E without Positive expiratory pressure during pause (PEP) |
Primary outcome
The average difference in PEF (Peak Expiratory Flow) in L/min with the use of the PEP function and without the use of this function.
Time frame: Between 5 and 15 minutes (MI-E treatment period)
We aim to study the effect of using PEP during the pause on cough peak expiratory flow (PEF) in patients with ALS during MI-E therapy. The PEF from all treatment cycles measured by an external pneumotachograph connected to the circuit between the machine and the patient will be averaged and compared between the arms: with and without PEP during the pause
5 secondary outcomes
The average difference in inspiratory volume in mililiters with the use of the PEP function and without the use of this function.
Time frame: Between 5 and 15 minutes (MI-E treatment period)
The perceived effect of PEP during pause on the effectiveness of MI-E therapy by the patient as well as their perceived comfort
Time frame: Between 5 and 15 minutes (MI-E treatment period)
Qualitative analysis of cough using flow/time graphs of patient coughs with the use of the PEP function and without the use of this function.
Time frame: Between 5 and 15 minutes (MI-E treatment period)
Comparison of PEF (Peak Expiratory Flow) reported by the MI-E machine versus PEF measured by the external pneumotachograph in L/min
Time frame: Between 5 and 15 minutes (MI-E treatment period)
Comparison of Inspiratory Volume reported by the MI-E machine versus Inspiratory Volume measured by the external pneumotachograph in mililiters
Time frame: Between 5 and 15 minutes (MI-E treatment period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI-E with PEP function activated during the pause and MI-E without PEP function activated during the pause in people with Amyotrophic Lateral Sclerosis ALS7, run by Groupe Hospitalier du Havre at 1 site 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yann Combret, PT, PhD (+332 32 73 32 32, yann.combret@ch-havre.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average difference in PEF (Peak Expiratory Flow) in L/min with the use of the PEP function and without the use of this function. (time frame: Between 5 and 15 minutes (MI-E treatment period)). 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 21 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.