Intensive Care UnitGLOBAL WEANNCT04222569
Determination of the Optimal Spontaneous Breathing Trial During Weaning of Mechanical Ventilation
A study testing T-piece, PSV 7 and PEEP 0 and PSV 0 and PEEP 0 in people with Intensive Care Unit and Invasive Mechanical Ventilation, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Assessment and comparison of three spontaneous breathing trials in five specific profiles of intensive care unit and perioperative patients. A physiological cross over study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, Invasive Mechanical Ventilation, Ready to Wean From Ventilation
- What is being tested?
- T-piece, PSV 7 and PEEP 0 and PSV 0 and PEEP 0
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2020to 15 Jun 2023
- 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
- ICU patient with invasive mechanical ventilation for at least 24 hours
- Physician decision to extubate and all criteria for ventilatory weaning must be present
- Resolution of disease acute phase for which the patient was intubated
- Conscious patient (Richmond Agitation-Sedation Scale (RASS) > 0), no sedation
- Good coughing effort, good swallowing, positive leak test (> 12% of tidal volume (VT))
- No important secretions
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- No respiratory acidosis, adequate oxygenation (PaO2 / FiO2 > 150 mmHg and CPAP ≤ 8)
- Adequate pulmonary function (respiratory rate (RR) ≤ 35, negative inspiratory force (NIF) > 20 cmH2O, RR/VT < 105)
- Stable cardiovascular status (heart rate (HR) < 140 bpm, systolic blood pressure > 90 mmHg, no or minimal vasopressors)
- If severe brain injury, the VISAGE score must be ≥ 3 (visual pursuit, good swallowing, GCS > 10)
Who cannot join
- Obese patients with BMI ≥ 35 kg/m2
- Contraindication for nasogastric tube or esophageal manometric balloon placement
- Refusal of study participation or to pursue the study by the patient, no consent
- Pregnancy or breastfeeding
- Absence of coverage by the French statutory healthcare insurance system
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire Saint Eloi
Montpellier, Herault, 34000
About this study
Official title: Determination of the Optimal Spontaneous Breathing Trial During Weaning of Mechanical Ventilation: a Randomized and Personalized Cross Over Physiologic Study in the Perioperative and Critically Ill Patient
Assessment and comparison of three spontaneous breathing trials in five specific profiles of intensive care unit and perioperative patients. A physiological cross over study
Read the detailed description
Mechanical ventilation is the most used organ replacement therapy in intensive care unit (ICU). After resolution of acute illness, separating the ventilator from the patient may be specially challenging. Before extubation, it is recommended to perform a spontaneous breathing trial (SBT) to evaluate the ability to sustain breathing with minimal or no support.
The way to carry out this step of the weaning process present important variation across regions of the world. Two techniques are preferentially used : the T-piece trial (oxygen supply without positive pressure) and low pressure support ventilation (PSV) from 6 to 10 cmH2O according to the airway humidification device.
The best strategy for successful weaning remains unknown, especially about specific subgroups of respiratory and neurological diseases.
Our aim is to assess which spontaneous breathing trial would best reproduce post-extubation inspiratory effort. We compare T-piece trial, PSV 7 cmH2O without positive end expiratory pressure (PEEP) and PSV 0 cmH2O without PEEP. Five specific profiles are evaluated : chronic obstructive pulmonary disease (COPD), severe brain injury, blunt thoracic trauma, post abdominal surgery and miscellaneous.
The hypothesis is that T-piece trial and PSV 0 CPAP 0 trial are the best for mimic inspiratory effort after extubation. However, we could highlight various results according to different subgroups of ICU patients. The final aim is to determine a personalized wean trial for each.
- Being tested
- T-piece, PSV 7 and PEEP 0, PSV 0 and PEEP 0
- Keywords
- Intensive Care Unit, Critical Care, Mechanical Ventilation Weaning, Spontaneous Breath Trial, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-pieceProcedure or surgery
Spontaneous breath trial with a T-piece
PSV 7 and PEEP 0Procedure or surgery
Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure
PSV 0 and PEEP 0Procedure or surgery
Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator
| Study group | Role | What they receive |
|---|---|---|
| T-piece and PSV 7 PEEP 0 and PSV 0 PEEP 0 | Experimental | First T-piece trial for 15 min. After 10 min of rest, PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. Receives: Procedure: T-piece; Procedure: PSV 7 and PEEP 0; Procedure: PSV 0 and PEEP 0 |
| T-piece and PSV 0 PEEP 0 and PSV 7 PEEP 0 | Experimental | First T-piece trial for 15 min. After 10 min of rest, PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. Receives: Procedure: T-piece; Procedure: PSV 7 and PEEP 0; Procedure: PSV 0 and PEEP 0 |
| PSV 0 PEEP 0 and PSV 7 PEEP 0 and T-piece | Experimental | First PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, T-piece trial for 15 min. Receives: Procedure: T-piece; Procedure: PSV 7 and PEEP 0; Procedure: PSV 0 and PEEP 0 |
| PSV 0 PEEP 0 and T-piece and PSV 7 PEEP 0 | Experimental | First PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, T-piece trial for 15 min. After 10 min of rest, PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. Receives: Procedure: T-piece; Procedure: PSV 7 and PEEP 0; Procedure: PSV 0 and PEEP 0 |
| PSV 7 PEEP 0 and T-piece and PSV 0 PEEP 0 | Experimental | First PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, T-piece trial for 15 min. After 10 min of rest, PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. Receives: Procedure: T-piece; Procedure: PSV 7 and PEEP 0; Procedure: PSV 0 and PEEP 0 |
| PSV 7 PEEP 0 and PSV 0 PEEP 0 and T-piece | Experimental | First PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, T-piece trial for 15 min. Receives: Procedure: T-piece; Procedure: PSV 7 and PEEP 0; Procedure: PSV 0 and PEEP 0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal Pressure Time Product per minute (PTPes.min)
In cmH2O.s/min. Assessment of patient's inspiratory effort. Integration of esophageal swing pressure over time, performed with a second-generation balloon esophageal catheter, immediately before and after each spontaneous breathing trial, before and 20 min after extubation
Measured: Day one
Secondary outcomes (2)
Esophageal Pressure Time Product per minute (PTPes.min)
In cmH2O.s/min. If esophageal catheter still in place, patient's inspiratory effort 24 hours after extubation
Measured: Day two
Esophageal Pressure Time Product per minute (PTPes.min)
In cmH2O.s/min. If esophageal catheter still in place, patient's inspiratory effort 48 hours after extubation.
Measured: Day three
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start15 Jun 2020
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Why it stopped: sufficient number of patients to meet objectives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each patient, serving as their own control, realize three SBT for 15 minutes: T-piece, PSV 7 cmH2O without PEEP and PSV 0 cmH2O without PEEP. The order is randomized. The randomization is stratified on pathology. For avoid a carry-over effect, a wash-out period of baseline ventilation for 10 minutes will be respected between trials. The humidification device is a heated humidifier, linked to the ventilator. Data are recorded before (guarantee of real return to baseline) and after each SBT. Then, extubation is decided by clinician in charge, in accordance with guidelines. A 30 min of resting period is respected before. Data are recorded before and 20 minutes after extubation.
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Jaber, MD, PHD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222569
- Sponsor's protocol ID
- RECHMPL19_0197
- Acronym
- GLOBAL WEAN
- Status last verified
- May 2026
- First submitted
- 9 Dec 2019
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data will be made available upon a reasonable request
Publications
Mahul M, Jung B, Galia F, Molinari N, de Jong A, Coisel Y, Vaschetto R, Matecki S, Chanques G, Brochard L, Jaber S. Spontaneous breathing trial and post-extubation work of breathing in morbidly obese critically ill patients. Crit Care. 2016 Oct 27;20(1):346. doi: 10.1186/s13054-016-1457-4.
PubMed 27784322Capdevila M, Aarab Y, Monet C, De Jong A, Vonarb A, Carr J, Molinari N, Capdevila X, Brochard L, Jaber S. Spontaneous breathing trials should be adapted for each patient according to the critical illness. A new individualised approach: the GLOBAL WEAN study. Intensive Care Med. 2024 Dec;50(12):2083-2093. doi: 10.1007/s00134-024-07657-4. Epub 2024 Oct 25.
PubMed 39453494Capdevila M, De Jong A, Aarab Y, Vonarb A, Carr J, Molinari N, Capdevila X, Brochard L, Jaber S. Which spontaneous breathing trial to predict effort to breathe after extubation according to five critical illnesses: the cross-over GLOBAL WEAN study protocol. BMJ Open. 2023 Jul 12;13(7):e070931. doi: 10.1136/bmjopen-2022-070931.
PubMed 37438068
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Optimal Spontaneous Breathing Trial During Weaning of Mechanical Ventilation: a Randomized and Personalized Cross Over Physiologic Study in the Perioperative and Critically Ill Patient
- ClinicalTrials.gov ID
- NCT04222569
- Acronym / sponsor ID
- GLOBAL WEAN / RECHMPL19_0197
- Keywords
- Intensive Care Unit, Critical Care, Mechanical Ventilation Weaning, Spontaneous Breath Trial, Rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sufficient number of patients to meet objectives
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 10 Jan 2020 (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.
Assessment and comparison of three spontaneous breathing trials in five specific profiles of intensive care unit and perioperative patients. A physiological cross over study
Detailed description
Mechanical ventilation is the most used organ replacement therapy in intensive care unit (ICU). After resolution of acute illness, separating the ventilator from the patient may be specially challenging. Before extubation, it is recommended to perform a spontaneous breathing trial (SBT) to evaluate the ability to sustain breathing with minimal or no support.
The way to carry out this step of the weaning process present important variation across regions of the world. Two techniques are preferentially used : the T-piece trial (oxygen supply without positive pressure) and low pressure support ventilation (PSV) from 6 to 10 cmH2O according to the airway humidification device.
The best strategy for successful weaning remains unknown, especially about specific subgroups of respiratory and neurological diseases.
Our aim is to assess which spontaneous breathing trial would best reproduce post-extubation inspiratory effort. We compare T-piece trial, PSV 7 cmH2O without positive end expiratory pressure (PEEP) and PSV 0 cmH2O without PEEP. Five specific profiles are evaluated : chronic obstructive pulmonary disease (COPD), severe brain injury, blunt thoracic trauma, post abdominal surgery and miscellaneous.
The hypothesis is that T-piece trial and PSV 0 CPAP 0 trial are the best for mimic inspiratory effort after extubation. However, we could highlight various results according to different subgroups of ICU patients. The final aim is to determine a personalized wean trial for each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Each patient, serving as their own control, realize three SBT for 15 minutes: T-piece, PSV 7 cmH2O without PEEP and PSV 0 cmH2O without PEEP. The order is randomized. The randomization is stratified on pathology. For avoid a carry-over effect, a wash-out period of baseline ventilation for 10 minutes will be respected between trials. The humidification device is a heated humidifier, linked to the ventilator. Data are recorded before (guarantee of real return to baseline) and after each SBT. Then, extubation is decided by clinician in charge, in accordance with guidelines. A 30 min of resting period is respected before. Data are recorded before and 20 minutes after extubation.
| Arm | Type | Receives |
|---|---|---|
| T-piece and PSV 7 PEEP 0 and PSV 0 PEEP 0 | Experimental | Procedure: T-piece, Procedure: PSV 7 and PEEP 0, Procedure: PSV 0 and PEEP 0First T-piece trial for 15 min. After 10 min of rest, PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. |
| T-piece and PSV 0 PEEP 0 and PSV 7 PEEP 0 | Experimental | Procedure: T-piece, Procedure: PSV 7 and PEEP 0, Procedure: PSV 0 and PEEP 0First T-piece trial for 15 min. After 10 min of rest, PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. |
| PSV 0 PEEP 0 and PSV 7 PEEP 0 and T-piece | Experimental | Procedure: T-piece, Procedure: PSV 7 and PEEP 0, Procedure: PSV 0 and PEEP 0First PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, T-piece trial for 15 min. |
| PSV 0 PEEP 0 and T-piece and PSV 7 PEEP 0 | Experimental | Procedure: T-piece, Procedure: PSV 7 and PEEP 0, Procedure: PSV 0 and PEEP 0First PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, T-piece trial for 15 min. After 10 min of rest, PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. |
| PSV 7 PEEP 0 and T-piece and PSV 0 PEEP 0 | Experimental | Procedure: T-piece, Procedure: PSV 7 and PEEP 0, Procedure: PSV 0 and PEEP 0First PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, T-piece trial for 15 min. After 10 min of rest, PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. |
| PSV 7 PEEP 0 and PSV 0 PEEP 0 and T-piece | Experimental | Procedure: T-piece, Procedure: PSV 7 and PEEP 0, Procedure: PSV 0 and PEEP 0First PSV 7 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, PSV 0 cmH2O and PEEP 0 cmH2O trial for 15 min. After 10 min of rest, T-piece trial for 15 min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ICU patient with invasive mechanical ventilation for at least 24 hours
- Physician decision to extubate and all criteria for ventilatory weaning must be present
- Resolution of disease acute phase for which the patient was intubated
- Conscious patient (Richmond Agitation-Sedation Scale (RASS) > 0), no sedation
- Good coughing effort, good swallowing, positive leak test (> 12% of tidal volume (VT))
Key exclusion criteria (5 listed)
- Obese patients with BMI ≥ 35 kg/m2
- Contraindication for nasogastric tube or esophageal manometric balloon placement
- Refusal of study participation or to pursue the study by the patient, no consent
- Pregnancy or breastfeeding
- Absence of coverage by the French statutory healthcare insurance system
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 |
|---|---|---|
| T-pieceSpontaneous breath trial with a T-piece | Procedure or surgery | PSV 0 PEEP 0 and PSV 7 PEEP 0 and T-piece, PSV 0 PEEP 0 and T-piece and PSV 7 PEEP 0, PSV 7 PEEP 0 and PSV 0 PEEP 0 and T-piece, PSV 7 PEEP 0 and T-piece and PSV 0 PEEP 0, T-piece and PSV 0 PEEP 0 and PSV 7 PEEP 0, T-piece and PSV 7 PEEP 0 and PSV 0 PEEP 0 |
| PSV 7 and PEEP 0Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure | Procedure or surgery | PSV 0 PEEP 0 and PSV 7 PEEP 0 and T-piece, PSV 0 PEEP 0 and T-piece and PSV 7 PEEP 0, PSV 7 PEEP 0 and PSV 0 PEEP 0 and T-piece, PSV 7 PEEP 0 and T-piece and PSV 0 PEEP 0, T-piece and PSV 0 PEEP 0 and PSV 7 PEEP 0, T-piece and PSV 7 PEEP 0 and PSV 0 PEEP 0 |
| PSV 0 and PEEP 0Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator | Procedure or surgery | PSV 0 PEEP 0 and PSV 7 PEEP 0 and T-piece, PSV 0 PEEP 0 and T-piece and PSV 7 PEEP 0, PSV 7 PEEP 0 and PSV 0 PEEP 0 and T-piece, PSV 7 PEEP 0 and T-piece and PSV 0 PEEP 0, T-piece and PSV 0 PEEP 0 and PSV 7 PEEP 0, T-piece and PSV 7 PEEP 0 and PSV 0 PEEP 0 |
Primary outcome
Esophageal Pressure Time Product per minute (PTPes.min)
Time frame: Day one
In cmH2O.s/min. Assessment of patient's inspiratory effort. Integration of esophageal swing pressure over time, performed with a second-generation balloon esophageal catheter, immediately before and after each spontaneous breathing trial, before and 20 min after extubation
2 secondary outcomes
Esophageal Pressure Time Product per minute (PTPes.min)
Time frame: Day two
Esophageal Pressure Time Product per minute (PTPes.min)
Time frame: Day three
Results and safety
The study was stopped early (reason given: sufficient number of patients to meet objectives). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 27784322Mahul M, Jung B, Galia F, Molinari N, de Jong A, Coisel Y, Vaschetto R, Matecki S, Chanques G, Brochard L, Jaber S. Spontaneous breathing trial and post-extubation work of breathing in morbidly obese critically ill patients. Crit Care. 2016 Oct 27;20(1):346. doi: 10.1186/s13054-016-1457-4.
- Results publication: PubMed 39453494Capdevila M, Aarab Y, Monet C, De Jong A, Vonarb A, Carr J, Molinari N, Capdevila X, Brochard L, Jaber S. Spontaneous breathing trials should be adapted for each patient according to the critical illness. A new individualised approach: the GLOBAL WEAN study. Intensive Care Med. 2024 Dec;50(12):2083-2093. doi: 10.1007/s00134-024-07657-4. Epub 2024 Oct 25.
- Derived from this study: PubMed 37438068Capdevila M, De Jong A, Aarab Y, Vonarb A, Carr J, Molinari N, Capdevila X, Brochard L, Jaber S. Which spontaneous breathing trial to predict effort to breathe after extubation according to five critical illnesses: the cross-over GLOBAL WEAN study protocol. BMJ Open. 2023 Jul 12;13(7):e070931. doi: 10.1136/bmjopen-2022-070931.
- Individual participant dataSharing planned: Yes. Individual patient data will be made available upon a reasonable request
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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.
Samir Jaber, MD, PHD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-piece, PSV 7 and PEEP 0 and PSV 0 and PEEP 0 in people with Intensive Care Unit and Invasive Mechanical Ventilation, run by University Hospital, Montpellier 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 10 inclusion and 5 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: stopped early, as of the sponsor's last update on 2 Jun 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?
The study was stopped early (reason given: sufficient number of patients to meet objectives). Results are not available in the source record.
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?
Esophageal Pressure Time Product per minute (PTPes.min) (time frame: Day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04222569, which also lists 3 linked publications.
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 2 Jun 2026.