Severe AsthmaNCT03984253
Swiss Severe Asthma Register
An observational study of Severe Asthma, run by Prof. Dr. Jörg Leuppi at 10 sites in Switzerland.
Trial summary
Asthma is one of the most common chronic diseases. Asthma is characterized by chronic airway inflammation and associated with airway hyperresponsiveness and reversible airflow obstruction. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Severe Asthma
- How many people
- 600 participants
- Where
- 10 sitesSwitzerland
- Study dates
- 13 May 2019to 28 Feb 2034
- How long will I take part?
- 15 Years
- Phase
- Observational
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting to participating study center (pulmonologists in private practice or in pulmonary departments in hospital within Switzerland)
Who may be able to join
- In- and outpatients
- Age ≥ 0 year
- Informed consent as documented by signature
- Adults:
- "Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5 asthma:
- High level therapy:
Show all 38Show fewer
- high dose ICS with ≥ 1000 μg beclomethasone (powder) or equivalent in combination with LABA or leukotriene modifier/theophylline) for the previous year or
- Daily long-term therapy with systemic corticosteroids (CS) for ≥50% of the previous year to prevent it from becoming "uncontrolled" or which remains "uncontrolled" despite this therapy or
- Therapy with monoclonal antibodies independent from the co-therapy
- Middle level therapy:
- Protokollsynopsis SAR Version 01 16.01.2019 Seite 4/10 a) Daily long-term therapy with medium-to high-dose ICS (≥500 μg Beclomethason (powder) or equivalent in combination with LABA or leukotriene modifier/theophylline) for the previous year and uncontrolled asthma defined as at least one of the following:
- Poor symptom control: ACQ consistently >1.5, ACT <20 (or "not well controlled" by NAEPP/GINA guidelines).
- Frequent severe exacerbations: two or more bursts of systemic CS (>3 days each) in the previous year.
- Serious exacerbations: at least one hospitalization, ICU stay or mechanical ventilation in the previous year.
- Airflow limitation: after appropriate bronchodilator withhold FEV1 <80% predicted (in the face of reduced FEV1/FVC defined as less than the lower limit of normal).
- Controlled asthma that worsens on tapering of these high doses of ICS or systemic CS (or additional biologics). The presence of any one of the following exclusion criteria will lead to exclusion of the patients:
- Life-expectancy <6 months
- Insufficient knowledge of project language
- Children:
- The criteria for severe or difficult asthma in children and adolescents are considered fulfilled in the case of insufficient symptom control in the last year despite medium/high antiinflammatory long-term therapy:
- age 0-18 years, at time of inclusion
- diagnosis of bronchial asthma made by a physician
- differential diagnoses excluded
- good compliance and trained inhalation technique
- treatment with biological approved for the treatment of severe asthma (currently only omalizumab) or
- Proof of:
- Positive Bronchodilation-test (≥12% increase in FEV1 after SABA) or b) Significant bronchial hyperresponsiveness after nonspecific provocation (e.g., with Methacholine or treadmill) according to ATS criteria (AJRCCM 2000)
- High level of therapy:
- Prolonged therapy with high dose inhaled steroid (ICS) (> 400 μg Budesonide equivalent /> 200 μg fluticasone alone); or
- Daily long-term therapy with medium- to high-dose ICS (≥ 400 μg Budesonide equivalent / ≥200 μg fluticasone) in combination with long-acting betaagonists and / or leukotriene receptor antagonist and / or theophylline; or
- Therapy with oral steroids fixed ≥3 last months.
- Insufficient asthma control
- Inadequate symptom control after NVL in the last 4 weeks: Protokollsynopsis SAR Version 01 16.01.2019 Seite 5/10
- ≥3 x weekly asthma symptoms or use of ondemand medication; Or:
- limited activity due to asthma; Or:
- any symptoms at night; or b. Exacerbation(s) ≥1 last year that required treatment with systemic steroids and / or inpatient treatment c. limited lung function:
- pathological Tiffeneau quotient or FEV1 at inclusion.
- Submission of a written consent (parent/ legal guardian).
Who cannot join
- Life-expectancy <6 months · Insufficient knowledge of project language
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Switzerland10 sites, 10 recruiting
- Recruiting
Universitätsklinik für Pneumologie, Inselspital
Bern
Nikolay Pavlov, MD, nikolay.pavlov@insel.ch
- Recruiting
Pneumologie, Kantonsspital Graubünden
Chur
Thomas Rothe, MD, thomas.rothe@gmx.ch
- Recruiting
Klinik für Pneumologie, Hochgebirgsklinik Davos
Davos
Hans-Werner Duchna, Professor, hans-werner.duchna@hgk.ch
- Recruiting
Hôpitaux Universitaires Genève
Geneva
Florian Charbonnier, MD, florian.charbonnier@hcuge.ch
- Recruiting
Centre hospitalier universitaire vaudoise
Lausanne
Christophe Von Garnier, Professor, christophe.von-garnier@chuv.ch
- Recruiting
Cantonal Hospital Baselland Liestal
Liestal, Basel-Landschaft, 4410
Jörg Leuppi, Professor, joerg.leuppi@ksbl.ch
- Recruiting
Pneumologia, Ospedale Civico
Lugano
Pietro Gianella, MD, pietro.gianella@eoc.ch
- Recruiting
Klinik für Pneumologie und Schlafmedizin, Kantonsspital St.Gallen
Sankt Gallen
Lucas Kern, MD, lukas.kern@kssg.ch
- Recruiting
Hôpital du valais, sion
Sion
Pierre-Olivier Bridevaux, Professor, pierre-olivier.bridevaux@hospitalvs.ch
- Recruiting
Klinik für Pneumologie, Universitätsspital Zürich
Zurich
Christian Clarenbach, MD, christian.clarenbach@usz.ch
About this study
Asthma is one of the most common chronic diseases. Asthma is characterized by chronic airway inflammation and associated with airway hyperresponsiveness and reversible airflow obstruction. The variability of airway obstruction is triggered by different factors that lead to a variety of different asthma phenotypes and subtypes. The various classification options for asthma (e.g. severity, by the predominantly existing inflammation or according to triggers), reflect its heterogeneity.
Despite improved therapeutic methods, the prevalence and morbidity of asthma has increased worldwide in the last years. Asthma is a serious and growing global health problem with around 300 million people affected, independent of age or sex. Estimated 250'000 people die prematurely each year due to their asthma.
Read more
Based on the SAPALDIA-study, the prevalence of Asthma in Switzerland is approximately 2-8%. Asthma is considered as a major factor in healthcare cost with up to CHF 1.2 billion per year. Asthma is not only a financial burden to a system; it affects the individual Quality of life negatively. Often health care professionals and patients underestimate the severity of the disease and overestimate asthma control. Severe asthma should not be equated with uncontrolled asthma. To reach a satisfying asthma control numerous factors need to be taken into consideration. Severe asthma is often associated with a high risk of frequent, severe exacerbations, which can even lead to death.
Several severe asthma cohorts and registries already exists and are reported in the literature. The aim of such registries is in general data collection and a better understanding of the disease. So far, most epidemiological studies on severe asthma are cross-sectional with no follow up measures. Only a few studies did repeated measures using the same methods.
Approximately 5% of all Asthma Patients suffers from severe asthma. These patients require systematic assessment and specialist care in dedicated respiratory centres. These centres have a key role in improving the outcome for severe asthma patients. At the same time they act as gatekeepers to ensure appropriate access to new, expensive therapies, this includes antibody treatment and interventional methods such as thermoplasty. These treatments require careful monitoring. It is important to ensure that they are given to the right population. Special assessment to monitor the efficacy and to prevent inappropriate prescribing, exposure of patients to unnecessary risks and excessive costs is indicated.
For all the mentioned reasons a Swiss Severe Asthma Register and a collaboration with an already existing register is needed to prospectively collect data about severe asthma in Switzerland.
Read the detailed description
The overall objective is to establish a clinical register for patients with severe asthma. Since the number of patients with severe asthma at a single center is usually low, it will be important to collect data in a multi-center system to optimize the diagnostic evaluation and treatment of patients with severe asthma. So far, there is little reliable information about the frequency, phenotype and therapy of patients with severe asthma. The construction of a clinical register should close this gap. The primary objective is to show changes in symptoms control during follow up period and at study end by using the Asthma Control Test (ACT). Secondary endpoints are to collect data to better understand asthma's natural history in patients with severe asthma. The examination will be based on the assessment of the parameters specified under "outcomes".
Patients presenting to participating study center (pulmonologists in private practice or in pulmonary departments in hospital within Switzerland) with severe asthma will be asked to take part in this study when corresponding to the eligibility criteria. All patients with severe asthma will be included in the register only after detailed information and written consent. After four months (for specific therapies) and after 12 months, patients should be re-evaluated for up to 15 years. These follow-up data will also be recorded in the register. During the follow-up visits, the same parameters will be collected as during the initial Baselineexamination (some parameters will be omitted, for example, therapy received or requested for the defined period of the last 12 months, etc.). Severe asthma patients receiving a new specific therapy, e.g. obtained with antibodies, but who cannot be included in the register with the complete parameter profile due to time or capacity reasons of the centers, should be recorded at least with defined basic data and a reduced number of parameters in the register. These parameters include according to the specific asthma approved specific therapies, socio-demographic data, lung function values, laboratory values, parameters of asthma control, smoking status and add-on- therapy. This should make it possible to record a subgroup of severe asthmatics that are suitable for antibody therapy and at the same time offer the attending physician the opportunity to adequately document these complex and expensive therapies by recording the defined parameters. In these patients, an evaluation of the therapy response should be carried out after four months and documented in the register. Thereafter, there is an annual follow-up. At any time, these patients can be transferred to the full version of the register by entering the missing parameters. Patients for whom only the basic data is available (basic version) as well as patients with complete parameter profile in the register are kept in the same database and can be evaluated together. In general, no register-specific examinations will be carried out, but only parameters anyway recorded routinely.
Since this is a cohort study, no sample size calculation can be calculated. Evaluations are carried out continuously. The collective of the data should be described by descriptive statistics concerning the basic data as well as the data of the function diagnostics. Subentities of severe asthma should be identified by a cluster analysis.
- Conditions
- Severe Asthma
- Keywords
- Asthma, Severe, Register
- Medical subject headings
- Asthma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Severe Asthma | All patients with severe asthma who will be treated in the participating centers should be continuously enrolled in the register. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Control
Changes in symptom control at baseline and during the follow-up period and at study end using the Asthma Control Test (ACT).
Measured: Baseline, four months, yearly for up to 15 years
Secondary outcomes (14)
Exacerbations
Number of exacerbation with/without hospitalization
Measured: Baseline, four months, yearly for up to 15 years
Utilization of the health care system
Number of Visits at one's general practitioner (GP) Number of Visits at a pneumologist/ specialist Number of emergency consultations Number of hospitalizations Number of rehabilitation stays
Measured: Baseline, four months, yearly for up to 15 years
Quality of Life Questionnaire
Mini Asthma Quality of Life Questionnaire(Mini-AQLQ)
- 15 Questions, Scale 1 to 7 , Minimum Score 15, Maximum Score 105.
- The higher the Score is, the better the quality of life
Measured: Baseline, four months, yearly for up to 15 years
Symptoms and health-related quality of life
Asthma Control Test 5 Questions, Scale 1- 5, Minimum score 5, max 25, the smaller the score the better is the Asthma control
Measured: Baseline, four months, yearly for up to 15 years
Changes in Medication
Changes in Medication will be monitored for each subject. Changes in dose in mg Changes in substances if there is a new drug used.
Measured: Baseline, four months, yearly for up to 15 years
Forced Vital Capacity (FVC)
Changes in FVC in liter and % from the target value
Measured: Baseline, after four months, and after 12 months, then every year up to 15 years
Forced Exahled Volume in 1 second (FEV1)
Changes in FEV1 in liter and % from the target value
Measured: Baseline, after four months, and after 12 months, then every year up to 15 years
Tiffeneau Test
Changes in Tiffeneau in % and % from Target Value
Measured: Baseline, after four months, and after 12 months, then every year up to 15 years
Fraction of exhaled nitric oxide, FENO
Changes in FENO in ppb
Measured: Baseline, after four months, and after 12 months, then every year up to 15 years
Blood Gas Aanalysis
pO2 in kPa/ mmHg pCO2 in kPa/ mmHg and Bloodoxygensaturation in %
Measured: Baseline, four months, yearly for up to 15 years
Leucozytes
Changes in Leucozytes in nl
Measured: Baseline, four months, yearly for up to 15 years
Neutrophilic granulocytes
in nl or %
Measured: Baseline, four months, yearly for up to 15 years
Eosinophilic granulocytes
in µl or %
Measured: Baseline, four months, yearly for up to 15 years
Mortality
Mortality rate due to severe Asthma
Measured: Baseline, four months, yearly for up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start13 May 2019
- Primary completion28 Feb 2034 (estimated)
- Study completion28 Feb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Jörg Leuppi
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, GlaxoSmithKline, Lungenliga Schweiz, Novartis
- Responsible party
- Sponsor-investigator, Prof. Dr. Jörg Leuppi, Cantonal Hospital, Baselland
- Investigators
- Jörg Leuppi, Principal investigator, Kantonsspital Baselland Liestal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984253
- Sponsor's protocol ID
- 2018-01553
- Other IDs
- 2018
- Status last verified
- Mar 2025
- First submitted
- 29 Apr 2019
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Severe Asthma Register
- ClinicalTrials.gov ID
- NCT03984253
- Acronym / sponsor ID
- 2018-01553
- Conditions
- Severe Asthma
- Keywords
- Asthma, Severe, Register
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Prof. Dr. Jörg LeuppiUniversity, hospital or other
- Collaborators
- AstraZeneca, GlaxoSmithKline, Lungenliga Schweiz, Novartis
- Study start
- 13 May 2019 (actual)
- Primary completion
- 28 Feb 2034 (estimated)
- Study completion
- 28 Feb 2034 (estimated)
- First posted
- 12 Jun 2019 (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 one of the most common chronic diseases. Asthma is characterized by chronic airway inflammation and associated with airway hyperresponsiveness and reversible airflow obstruction. The variability of airway obstruction is triggered by different factors that lead to a variety of different asthma phenotypes and subtypes. The various classification options for asthma (e.g. severity, by the predominantly existing inflammation or according to triggers), reflect its heterogeneity.
Despite improved therapeutic methods, the prevalence and morbidity of asthma has increased worldwide in the last years. Asthma is a serious and growing global health problem with around 300 million people affected, independent of age or sex. Estimated 250'000 people die prematurely each year due to their asthma.
Based on the SAPALDIA-study, the prevalence of Asthma in Switzerland is approximately 2-8%. Asthma is considered as a major factor in healthcare cost with up to CHF 1.2 billion per year. Asthma is not only a financial burden to a system; it affects the individual Quality of life negatively. Often health care professionals and patients underestimate the severity of the disease and overestimate asthma control. Severe asthma should not be equated with uncontrolled asthma. To reach a satisfying asthma control numerous factors need to be taken into consideration. Severe asthma is often associated with a high risk of frequent, severe exacerbations, which can even lead to death.
Several severe asthma cohorts and registries already exists and are reported in the literature. The aim of such registries is in general data collection and a better understanding of the disease. So far, most epidemiological studies on severe asthma are cross-sectional with no follow up measures. Only a few studies did repeated measures using the same methods.
Approximately 5% of all Asthma Patients suffers from severe asthma. These patients require systematic assessment and specialist care in dedicated respiratory centres. These centres have a key role in improving the outcome for severe asthma patients. At the same time they act as gatekeepers to ensure appropriate access to new, expensive therapies, this includes antibody treatment and interventional methods such as thermoplasty. These treatments require careful monitoring. It is important to ensure that they are given to the right population. Special assessment to monitor the efficacy and to prevent inappropriate prescribing, exposure of patients to unnecessary risks and excessive costs is indicated.
For all the mentioned reasons a Swiss Severe Asthma Register and a collaboration with an already existing register is needed to prospectively collect data about severe asthma in Switzerland.
Detailed description
The overall objective is to establish a clinical register for patients with severe asthma. Since the number of patients with severe asthma at a single center is usually low, it will be important to collect data in a multi-center system to optimize the diagnostic evaluation and treatment of patients with severe asthma. So far, there is little reliable information about the frequency, phenotype and therapy of patients with severe asthma. The construction of a clinical register should close this gap. The primary objective is to show changes in symptoms control during follow up period and at study end by using the Asthma Control Test (ACT). Secondary endpoints are to collect data to better understand asthma's natural history in patients with severe asthma. The examination will be based on the assessment of the parameters specified under "outcomes".
Patients presenting to participating study center (pulmonologists in private practice or in pulmonary departments in hospital within Switzerland) with severe asthma will be asked to take part in this study when corresponding to the eligibility criteria. All patients with severe asthma will be included in the register only after detailed information and written consent. After four months (for specific therapies) and after 12 months, patients should be re-evaluated for up to 15 years. These follow-up data will also be recorded in the register. During the follow-up visits, the same parameters will be collected as during the initial Baselineexamination (some parameters will be omitted, for example, therapy received or requested for the defined period of the last 12 months, etc.). Severe asthma patients receiving a new specific therapy, e.g. obtained with antibodies, but who cannot be included in the register with the complete parameter profile due to time or capacity reasons of the centers, should be recorded at least with defined basic data and a reduced number of parameters in the register. These parameters include according to the specific asthma approved specific therapies, socio-demographic data, lung function values, laboratory values, parameters of asthma control, smoking status and add-on- therapy. This should make it possible to record a subgroup of severe asthmatics that are suitable for antibody therapy and at the same time offer the attending physician the opportunity to adequately document these complex and expensive therapies by recording the defined parameters. In these patients, an evaluation of the therapy response should be carried out after four months and documented in the register. Thereafter, there is an annual follow-up. At any time, these patients can be transferred to the full version of the register by entering the missing parameters. Patients for whom only the basic data is available (basic version) as well as patients with complete parameter profile in the register are kept in the same database and can be evaluated together. In general, no register-specific examinations will be carried out, but only parameters anyway recorded routinely.
Since this is a cohort study, no sample size calculation can be calculated. Evaluations are carried out continuously. The collective of the data should be described by descriptive statistics concerning the basic data as well as the data of the function diagnostics. Subentities of severe asthma should be identified by a cluster analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Asthma | – | –All patients with severe asthma who will be treated in the participating centers should be continuously enrolled in the register. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting to participating study center (pulmonologists in private practice or in pulmonary departments in hospital within Switzerland)
Key inclusion criteria (38 listed)
- In- and outpatients
- Age ≥ 0 year
- Informed consent as documented by signature
- "Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5 asthma:
- High level therapy:
Key exclusion criteria (1 listed)
- Life-expectancy <6 months · Insufficient knowledge of project language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptom Control
Time frame: Baseline, four months, yearly for up to 15 years
Changes in symptom control at baseline and during the follow-up period and at study end using the Asthma Control Test (ACT).
14 secondary outcomes
Exacerbations
Time frame: Baseline, four months, yearly for up to 15 years
Utilization of the health care system
Time frame: Baseline, four months, yearly for up to 15 years
Quality of Life Questionnaire
Time frame: Baseline, four months, yearly for up to 15 years
Symptoms and health-related quality of life
Time frame: Baseline, four months, yearly for up to 15 years
Changes in Medication
Time frame: Baseline, four months, yearly for up to 15 years
Forced Vital Capacity (FVC)
Time frame: Baseline, after four months, and after 12 months, then every year up to 15 years
Forced Exahled Volume in 1 second (FEV1)
Time frame: Baseline, after four months, and after 12 months, then every year up to 15 years
Tiffeneau Test
Time frame: Baseline, after four months, and after 12 months, then every year up to 15 years
Fraction of exhaled nitric oxide, FENO
Time frame: Baseline, after four months, and after 12 months, then every year up to 15 years
Blood Gas Aanalysis
Time frame: Baseline, four months, yearly for up to 15 years
Leucozytes
Time frame: Baseline, four months, yearly for up to 15 years
Neutrophilic granulocytes
Time frame: Baseline, four months, yearly for up to 15 years
Eosinophilic granulocytes
Time frame: Baseline, four months, yearly for up to 15 years
Mortality
Time frame: Baseline, four months, yearly for up to 15 years
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 12 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jörg Leuppi principal investigator
Kantonsspital Baselland Liestal
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by Prof. Dr. Jörg Leuppi at 10 sites in Switzerland.
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 38 inclusion and 1 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 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Switzerland. 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 Jörg Leuppi (+41619252181, Joerg.leuppi@ksbl.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Control (time frame: Baseline, four months, yearly for up to 15 years). 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 12 Mar 2025.