AsthmaPhase 4SECURENCT05626777
Symptoms Control and adhErenCe Assessment During Treatment With MepolizUmab New pREfilled Devices
A Phase 4 study testing Pre-filled syringe, mepolizumab 100 mg/month and Auto-injector pen, mepolizumab 100 mg/month in people with Asthma, run by Hospices Civils de Lyon at 8 sites in France.
Trial summary
Asthma is a common pathology, with a prevalence of 6 to 8% and more than 4 million patients in France. Its management is based on different therapeutic axes. Their use is very dependent on disease control, with therapeutic escalation, from treatment on demand to a combination of them at high dosage, according to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Pre-filled syringe, mepolizumab 100 mg/month and Auto-injector pen, mepolizumab 100 mg/month
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesFrance
- Study dates
- 9 Mar 2023to Jul 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged ≥ 18 years
- Severe asthma diagnosed by a pulmonologist and followed for at least a year
- Blood eosinophilia ≥ 0.15 G / L in the 12 months preceding inclusion in the trial.
- At least 2 exacerbations in the past 12 months, each time treated with oral corticosteroid therapy or an increase in dosage of oral corticosteroid therapy prescribed for a long time, for at least 72 hours.
- High dose inhaled corticosteroid therapy (> 800 μg / d budesonide,> 500 μg / d fluticasone,> 1000 μg / d beclometasone, etc.) and at least one second controller asthma treatment with Long-Acting Beta-Agonists or Long-Acting Muscarinic Antagonists
- Patient must have an efficient contraception method
- Patient affiliated to a social security scheme.
- Patient able to give free, informed and written consent.
Who cannot join
- Pregnant woman (urinary beta-HCG positive at inclusion) or breastfeeding
- Active smoking or ex-smoking for less than 6 months and more than 10 pack-years
- Exacerbation in the 4 weeks preceding first Mepolizumab injection
- Patient who has already been treated with Mepolizumab or another anti-IL-5 or -5R treatment
- Patient currently using a biotherapy indicated in severe asthma other than anti-IL5 or 5R treatments or stopped for less than 2 months
- Treatment underway with another biotherapy not indicated for severe asthma
Show all 10Show fewer
- Patient participating in other interventional research, excluding routine care research (old regulation) and category 2 research not interfering with primary endpoint analysis
- Other chronic respiratory pathology (bronchiectasis, chronic obstructive pulmonary disease, pulmonary fibrosis, etc.)
- Any other uncontrolled chronic pathology, the presence of which would be considered incompatible with the performance of the study by the investigator
- Patient under guardianship, curatorship or legal protection
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Service de Pneumologie CHU Besançon
Besançon, 25030
Service de Pneumologie CHU Dijon
Dijon, 21079
Service de Pneumologie et ImmunoAllergologie CHU Lille
Lille, 59045
Departement of Pulmonology, Croix-Rousse Hospital, Hospices Civils de Lyon
Lyon, 69004
Service des Maladies Respiratoires CHU Montpellier
Montpellier
Service de Pneumologie A APHP Bichat
Paris, 75018
Service des Maladies Respiratoires CHU Reims
Reims, 51092
Service de Pneumologie CHU Toulouse
Toulouse, 31059
About this study
Asthma is a common pathology, with a prevalence of 6 to 8% and more than 4 million patients in France. Its management is based on different therapeutic axes. Their use is very dependent on disease control, with therapeutic escalation, from treatment on demand to a combination of them at high dosage, according to the severe asthma's phenotype.
Despite these effective therapeutic tools, there is a lack of control of the disease in the vast majority of cases, affecting at least 60% of asthmatics. Among the factors associated with lack of control, non-compliance with inhaled therapies is frequent and requires to be systematically assessed in the absence of control.
Read more
Its evaluation by definition is complex and variously appreciated, fluctuating from 40 to 80%. The means proposed for evaluating it involve doctor/patient interviews, evaluation of the therapeutic response, questionnaires, evaluation of drug consumption (evaluation of number of empty boxes, integrated electronic device, withdrawal of drugs from pharmacies, etc).
Asthma control is commonly evaluated using the validated Asthma Control Test score, in clinical practice and/or in research fields. An ACT score greater than 20 indicates well-controlled asthma. In addition, a change of at least 3 points is likely to indicate a clinically meaningful change in asthma control (Minimally Clinical Important Difference) in an individual patient over time and a change of 4 points or more further reduces the risk that the change is due to measurement error.
In the context of severe eosinophilic asthma, Mepolizumab has shown its benefit in controlling asthma, reducing the number of exacerbations and its ability to decrease the use of oral corticosteroids (MENSA, SIRIUS).
Mepolizumab is now available in 2 new "ready-to-use" forms: a pre-filled syringe and an auto-injector pen. Both systems can be administered at home either by a nurse or by the patient himself (self-administration). The choice is left to the discretion of the prescribing pulmonologist.
These new possibilities of Mepolizumab administration offer greater freedom to the patient, possibly allowing him to empower himself by carrying out his own treatment, without constraint and without being dependent on the availability of a nurse or another healthcare professional qualified to inject Mepolizumab.
These new methods of Mepolizumab self- administration also open the field to therapeutic non-compliance, a new problem in the field of biotherapies used for the treatment of severe asthma.
The investigator hypothesize a potential therapeutic non-compliance associated with the new method of administration of Mepolizumab, with self-injection by the patient, without the assistance of a nurse.
To assess this problem, the investigator propose to compare in a therapeutic trial Mepolizumab administered by pre-filled syringe by a home nurse every month versus Mepolizumab self-administered by auto-injector pen by the patient every month.
- Conditions
- Asthma
- Being tested
- Pre-filled syringe, mepolizumab 100 mg/month, Auto-injector pen, mepolizumab 100 mg/month
- Keywords
- Pulmonary Medicine, severe asthma, uncontrolled, mepolizumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-filled syringe, mepolizumab 100 mg/monthDrug
Pre-filled syringe, mepolizumab, 100 mg/month, 6 first months of treatment administered by nurse, 6 last months of treatment administered by patient
Auto-injector pen, mepolizumab 100 mg/monthDrug
Auto-injector pen, mepolizumab, 100 mg/month 12 months of treatment administered by patient
| Study group | Role | What they receive |
|---|---|---|
| Pre-filled syringe, mepolizumab 100 mg/month | Experimental | Pre-filled syringe, mepolizumab, 100 mg/month, 6 first months of treatment administered by nurse, 6 last months of treatment administered by patient Receives: Drug: Pre-filled syringe, mepolizumab 100 mg/month |
| Auto-injector pen, mepolizumab 100 mg/month | Experimental | Auto-injector pen, mepolizumab, 100 mg/month 12 months of treatment administered by patient Receives: Drug: Auto-injector pen, mepolizumab 100 mg/month |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare asthma control after 6 months of treatment between: A1 Group of patients using a pre-filled syringe administered monthly by a nurse, using a pre-filled syringe B1 Group of patients receiving self-administered monthly, using an auto-injector pen
Proportion of patients with controlled asthma using the ACT score (asthma control test), after a period of 6 months of treatment with Mepolizumab will be compared between groups of patients.
The ACT score is a single score varying from 5 to 25 points. Asthma is considered to be controlled when the ACT score is ≥ 20. In the study, asthma will be considered controlled if the ACT score is ≥ 20 or better controlled if it increases by at least 4 points during the treatment period.
Measured: MONTHS 6
Secondary outcomes (17)
Compare asthma control a. between groups A2 and B2 (see study design §4 below for groups description) b. between groups A1 and A2 c. between groups B1 and B2
Proportion of patients with asthma control assessed by the ACT score between:
- The group of patients receiving Mepolizumab self-administered monthly, using PFS and the group of patients receiving Mepolizumab self-administered monthly using an AI from 6 months to 12 months (between groups A2 and B2)
- Mepolizumab administered by a PFS by a nurse for the first 6 months and self-administered by a PFS for the following 6 months in the same group of patients (between groups A1 and A2)
- Mepolizumab self-administered by an AI during the first 6 months and self-administered by an AI the following 6 months in the same group of patients (between groups B1 and B2).
Measured: MONTHS 12
Compare Mean change in Asthma Control Test (ACT) score in each group
Comparison of the mean change in ACT score from baseline between groups: A1 vs B1, A2 vs B2, A1 vs A2, B1 vs B2, and A vs B
Measured: months 12
Compare the proportion of patients with an ACT score change of at least 4 points in each group
Comparison of the proportion of patients with a change in ACT score of at least 4 points from baseline between groups: A1 vs B1, A2 vs B2, A1 vs A2, B1 vs B2, and A vs B
Measured: months 12
Compare the number of exacerbation of asthma after 6 and 12 months of treatment (between A and B)
Comparison of the proportion of patients with an exacerbation of asthma during the 12 months of treatment (between groups A and B)
Measured: months 12
Compare the number of exacerbation of asthma requiring a visit to the emergency service or hospitalization after 6 and 12 months of treatment (between A and B)
Comparison of the proportion of patients with an exacerbation of asthma requiring an emergency service visit or hospitalization during the 12 months of treatment (between groups A and B)
Measured: months 12
Compare the change of exacerbation of asthma before and during the 12 months of treatment between A et B
Comparison of the proportion of patients with an exacerbation of asthma during the 12 months of treatment with Mepolizumab versus the proportion of patients with an exacerbation of asthma during the 12 months prior to treatment with Mepolizumab
Measured: months 12
Compare the proportion of patients requiring unscheduled medical consultation for asthma, after 12 months of treatment between A et B
The proportion of patients requiring unscheduled medical consultation for asthma during the 12 months of treatment (between groups A and B)
Measured: months 12
Compare oral corticosteroids consumption before and after Mepolizumab between group A and B
Cumulative dose of oral corticosteroids before and after 12 months of treatment with Mepolizumab (exacerbation treatment excluded) between group A and B
Measured: months 12
Compare treatment compliance between groups A and B
Treatment compliance using the MARS-5 questionnaire administered after 6 and 12 months of treatment with Mepolizumab. The MARS-5 score will be compared between both groups of patients.
Measured: months 12
Compare bronchial inflammation by measurement of Fraction of exhaled Nitric Oxide (FeNO) after 6 and 12 months of treatment (between groups A and B)
Carrying out a FeNO at V1, V2 and V3 after 6 and 12 months of Mepolizumab treatment between groups A and B
Measured: months 12
Compare blood eosinophilia evolution after 6 and 12 months of treatment in each grouporal corticosteroids consumption before and after Mepolizumab between group A and B
Performing a hemogram on peripheral blood to measure eosinophilia evolution at M0, M3, M6, M9 and M12
Measured: Months 0, 3, 6, 9, 12
Compare respiratory function measurement after 6 and 12 months of treatment (between A and B)
First measurement : Forced Exhaled Volume 1 (FEV1) Second measurement : Forced Vital Capacity (FVC) These two measurements are volumes which will be aggregated in order to obtain one final outcome measurement : FEV1/FVC in %
Measured: months 1, 6 12
Compare the safety of treatment with Mepolizumab
Collection of adverse events related to the study treatment throughout the study
Measured: Months 12
Compare the patients' quality of life in each group
Calculation of the mini-AQLQ quality of life score at V1, V2 and V3
Measured: months 1, 6 12
Compare the patients' quality of life in each group
Calculation of the SNOT-22 score at V1, V2 and V3
Measured: months 1, 6 12
Compare the patient satisfaction regarding asthma treatment in each group
Patient satisfaction questionnaire SATQ-F at Visit 1, Visit 2 and Visit 3 and assessment of the preferences of patients in each group with respect to the Mepolizumab administration system at Visit 1, Visit 2 and Visit 3
Measured: months 1, 6 12
dyspnea
Calculation of mMRC score at Visit 1, Visit 2 and Visit 3
Measured: months 1, 6 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start9 Mar 2023
- Primary completionMar 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Gilles Devouassoux, Pr, Principal investigator, Departement of Pulmonology, Croix-Rousse Hospital, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626777
- Sponsor's protocol ID
- 69HCL21_0419
- Other IDs
- 2022-501029-19-00
- Acronym
- SECURE
- Status last verified
- Nov 2024
- First submitted
- 5 Oct 2022
- Last updated
- 18 Nov 2024
- 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 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms Control and adhErenCe Assessment During Treatment With MepolizUmab New pREfilled Devices
- ClinicalTrials.gov ID
- NCT05626777
- Acronym / sponsor ID
- SECURE / 69HCL21_0419
- Conditions
- Asthma
- Keywords
- Pulmonary Medicine, severe asthma, uncontrolled, mepolizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 25 Nov 2022 (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.
Asthma is a common pathology, with a prevalence of 6 to 8% and more than 4 million patients in France. Its management is based on different therapeutic axes. Their use is very dependent on disease control, with therapeutic escalation, from treatment on demand to a combination of them at high dosage, according to the severe asthma's phenotype.
Despite these effective therapeutic tools, there is a lack of control of the disease in the vast majority of cases, affecting at least 60% of asthmatics. Among the factors associated with lack of control, non-compliance with inhaled therapies is frequent and requires to be systematically assessed in the absence of control.
Its evaluation by definition is complex and variously appreciated, fluctuating from 40 to 80%. The means proposed for evaluating it involve doctor/patient interviews, evaluation of the therapeutic response, questionnaires, evaluation of drug consumption (evaluation of number of empty boxes, integrated electronic device, withdrawal of drugs from pharmacies, etc).
Asthma control is commonly evaluated using the validated Asthma Control Test score, in clinical practice and/or in research fields. An ACT score greater than 20 indicates well-controlled asthma. In addition, a change of at least 3 points is likely to indicate a clinically meaningful change in asthma control (Minimally Clinical Important Difference) in an individual patient over time and a change of 4 points or more further reduces the risk that the change is due to measurement error.
In the context of severe eosinophilic asthma, Mepolizumab has shown its benefit in controlling asthma, reducing the number of exacerbations and its ability to decrease the use of oral corticosteroids (MENSA, SIRIUS).
Mepolizumab is now available in 2 new "ready-to-use" forms: a pre-filled syringe and an auto-injector pen. Both systems can be administered at home either by a nurse or by the patient himself (self-administration). The choice is left to the discretion of the prescribing pulmonologist.
These new possibilities of Mepolizumab administration offer greater freedom to the patient, possibly allowing him to empower himself by carrying out his own treatment, without constraint and without being dependent on the availability of a nurse or another healthcare professional qualified to inject Mepolizumab.
These new methods of Mepolizumab self- administration also open the field to therapeutic non-compliance, a new problem in the field of biotherapies used for the treatment of severe asthma.
The investigator hypothesize a potential therapeutic non-compliance associated with the new method of administration of Mepolizumab, with self-injection by the patient, without the assistance of a nurse.
To assess this problem, the investigator propose to compare in a therapeutic trial Mepolizumab administered by pre-filled syringe by a home nurse every month versus Mepolizumab self-administered by auto-injector pen by the patient every month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-filled syringe, mepolizumab 100 mg/month | Experimental | Drug: Pre-filled syringe, mepolizumab 100 mg/monthPre-filled syringe, mepolizumab, 100 mg/month, 6 first months of treatment administered by nurse, 6 last months of treatment administered by patient |
| Auto-injector pen, mepolizumab 100 mg/month | Experimental | Drug: Auto-injector pen, mepolizumab 100 mg/monthAuto-injector pen, mepolizumab, 100 mg/month 12 months of treatment administered by patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient aged ≥ 18 years
- Severe asthma diagnosed by a pulmonologist and followed for at least a year
- Blood eosinophilia ≥ 0.15 G / L in the 12 months preceding inclusion in the trial.
- At least 2 exacerbations in the past 12 months, each time treated with oral corticosteroid therapy or an increase in dosage of oral corticosteroid therapy prescribed for a long time, for at least 72 hours.
- High dose inhaled corticosteroid therapy (> 800 μg / d budesonide,> 500 μg / d fluticasone,> 1000 μg / d beclometasone, etc.) and at least one second controller asthma treatment with Long-Acting Beta-Agonists or Long-Acting Muscarinic Antagonists
Key exclusion criteria (10 listed)
- Pregnant woman (urinary beta-HCG positive at inclusion) or breastfeeding
- Active smoking or ex-smoking for less than 6 months and more than 10 pack-years
- Exacerbation in the 4 weeks preceding first Mepolizumab injection
- Patient who has already been treated with Mepolizumab or another anti-IL-5 or -5R treatment
- Patient currently using a biotherapy indicated in severe asthma other than anti-IL5 or 5R treatments or stopped for less than 2 months
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 |
|---|---|---|
| Pre-filled syringe, mepolizumab 100 mg/monthPre-filled syringe, mepolizumab, 100 mg/month, 6 first months of treatment administered by nurse, 6 last months of treatment administered by patient | Drug | Pre-filled syringe, mepolizumab 100 mg/month |
| Auto-injector pen, mepolizumab 100 mg/monthAuto-injector pen, mepolizumab, 100 mg/month 12 months of treatment administered by patient | Drug | Auto-injector pen, mepolizumab 100 mg/month |
Primary outcome
Compare asthma control after 6 months of treatment between: A1 Group of patients using a pre-filled syringe administered monthly by a nurse, using a pre-filled syringe B1 Group of patients receiving self-administered monthly, using an auto-injector pen
Time frame: MONTHS 6
Proportion of patients with controlled asthma using the ACT score (asthma control test), after a period of 6 months of treatment with Mepolizumab will be compared between groups of patients. The ACT score is a single score varying from 5 to 25 points. Asthma is considered to be controlled when the ACT score is ≥ 20. In the study, asthma will be considered controlled if the ACT score is ≥ 20 or better controlled if it increases by at least 4 points during the treatment period.
17 secondary outcomes
Compare asthma control a. between groups A2 and B2 (see study design §4 below for groups description) b. between groups A1 and A2 c. between groups B1 and B2
Time frame: MONTHS 12
Compare Mean change in Asthma Control Test (ACT) score in each group
Time frame: months 12
Compare the proportion of patients with an ACT score change of at least 4 points in each group
Time frame: months 12
Compare the number of exacerbation of asthma after 6 and 12 months of treatment (between A and B)
Time frame: months 12
Compare the number of exacerbation of asthma requiring a visit to the emergency service or hospitalization after 6 and 12 months of treatment (between A and B)
Time frame: months 12
Compare the change of exacerbation of asthma before and during the 12 months of treatment between A et B
Time frame: months 12
Compare the proportion of patients requiring unscheduled medical consultation for asthma, after 12 months of treatment between A et B
Time frame: months 12
Compare oral corticosteroids consumption before and after Mepolizumab between group A and B
Time frame: months 12
Compare treatment compliance between groups A and B
Time frame: months 12
Compare bronchial inflammation by measurement of Fraction of exhaled Nitric Oxide (FeNO) after 6 and 12 months of treatment (between groups A and B)
Time frame: months 12
Compare blood eosinophilia evolution after 6 and 12 months of treatment in each grouporal corticosteroids consumption before and after Mepolizumab between group A and B
Time frame: Months 0, 3, 6, 9, 12
Compare respiratory function measurement after 6 and 12 months of treatment (between A and B)
Time frame: months 1, 6 12
Compare the safety of treatment with Mepolizumab
Time frame: Months 12
Compare the patients' quality of life in each group
Time frame: months 1, 6 12
Compare the patients' quality of life in each group
Time frame: months 1, 6 12
Compare the patient satisfaction regarding asthma treatment in each group
Time frame: months 1, 6 12
dyspnea
Time frame: months 1, 6 12
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 18 Nov 2024.
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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.
Gilles Devouassoux, Pr principal investigator
Departement of Pulmonology, Croix-Rousse Hospital, Hospices Civils de Lyon
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pre-filled syringe, mepolizumab 100 mg/month and Auto-injector pen, mepolizumab 100 mg/month in people with Asthma, run by Hospices Civils de Lyon at 8 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 8 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare asthma control after 6 months of treatment between: A1 Group of patients using a pre-filled syringe administered monthly by a nurse, using a pre-filled syringe B1 Group of patients receiving self-administered monthly, using an auto-injector pen (time frame: MONTHS 6). 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 18 Nov 2024.