Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseOPTIVENT-COPDNCT07508943
Decision-making and Optimization of Ventilatory Support for AECOPD Patients
An observational study of Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
The goal of this retrospective observational study is to learn about how respiratory support is selected and adjusted in hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2026to 18 Mar 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will be selected retrospectively from hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease . The source population includes patients receiving routine inpatient care, with particular relevance to critically ill patients with high-quality intensive care data. Eligible participants will be identified from hospital clinical information systems and electronic medical records based on diagnosis, respiratory support records, and availability of dynamic clinical data collected during hospitalization.
Who may be able to join
- Hospitalized patients with a documented diagnosis of acute exacerbation of chronic obstructive pulmonary disease.
- Patients identified retrospectively from hospital records during the predefined study period.
- Patients who received at least one form of respiratory support during the index hospitalization, including conventional oxygen therapy, high-flow nasal cannula oxygen therapy, noninvasive ventilation, or invasive mechanical ventilation.
- Patients with available clinical records containing sufficient dynamic physiological, laboratory, and treatment-related data for retrospective analysis.
Who cannot join
- Patients whose hospitalization was not primarily due to acute exacerbation of COPD, even if COPD was documented as a comorbidity.
- Patients with stable COPD and no evidence of acute exacerbation during the index hospitalization.
- Patients admitted primarily for other acute conditions, including but not limited to pneumonia without documented AECOPD, acute heart failure, pulmonary embolism, pneumothorax, asthma exacerbation, trauma, or postoperative care.
- Patients with insufficient documentation to confirm AECOPD as the primary reason for admission.
- Patients with incomplete clinical records preventing retrospective analysis.
- Repeated hospitalizations of the same patient during the study period, with only the first eligible admission included.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
About this study
The goal of this retrospective observational study is to learn about how respiratory support is selected and adjusted in hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The main questions it aims to answer are:
- How are different respiratory support modalities selected for patients with AECOPD in real-world practice?
- What clinical patterns are associated with escalation, de-escalation, switching, or discontinuation of respiratory support during hospitalization? Researchers will review de-identified hospital records of patients admitted with AECOPD and analyze the dynamic use of respiratory support during hospitalization, including conventional oxygen therapy, high-flow nasal cannula oxygen therapy, non-invasive ventilation, and invasive mechanical ventilation.
Participants will not receive any study-assigned intervention. The study will use existing clinical data collected during routine inpatient care and will not change diagnosis, treatment, or follow-up.
Read the detailed description
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a major cause of hospitalization, respiratory failure, and poor clinical outcomes in patients with chronic obstructive pulmonary disease. Respiratory support is a key component of acute management and commonly includes conventional oxygen therapy (COT), high-flow nasal cannula oxygen therapy (HFNC), non-invasive ventilation (NIV), and invasive mechanical ventilation (IMV). In clinical practice, respiratory support decisions are not static; rather, they involve a dynamic and sequential process of initial selection, reassessment, escalation, de-escalation, switching, and withdrawal according to changes in patient condition. Inappropriate timing of escalation or unnecessary use of higher-intensity support may contribute to treatment failure and unfavorable outcomes.
This study is a retrospective observational study based on routinely collected clinical data from hospitalized patients with AECOPD. Using historical data extracted from hospital clinical information systems and electronic medical records, the study will systematically characterize respiratory support pathways during hospitalization and examine how support strategies are adjusted over time in response to changes in disease status. The study will not introduce any additional tests, procedures, or interventions, and will not alter prior or current clinical care.
The analytical framework of the study is based on sequential decision analysis. Patient condition will be reassessed at fixed time intervals during hospitalization using key physiological and monitoring parameters recorded in routine care. These indicators will be integrated into clinically interpretable disease-state strata, and each state will be linked to the respiratory support modality being used at that stage. The respiratory support decision at the subsequent stage will then be characterized as maintenance, escalation, de-escalation, switching, or discontinuation. Under clinically reasonable safety and feasibility constraints, retrospective data will be used to summarize the statistical patterns of disease evolution and outcomes associated with different respiratory support choices. Dynamic programming methods will be applied to explore interpretable sequential decision patterns aligned with relevant clinical goals, such as reducing treatment failure and intubation-related adverse outcomes, while avoiding unnecessary use of high-intensity support and excessive switching between modalities.
Data used in this study will be derived entirely from existing inpatient records and will include demographic and baseline information, disease- and hospitalization-related information, key physiological and monitoring indicators, respiratory support records, and outcome-related information such as treatment escalation, intubation, and in-hospital outcomes. All data will be retrospectively extracted and de-identified before analysis. Only authorized research personnel will have access to the study database. Study findings will be reported in aggregate form, and no personally identifiable information will be disclosed.
Because this study uses previously collected clinical data only, does not involve direct participant contact, and does not affect clinical management, a waiver of informed consent will be sought in accordance with institutional ethics requirements.
- Keywords
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Decision-Making, Real-World Data, Dynamic Programming, Respiratory Support
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 |
|---|---|---|
| AECOPD group | Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) identified from historical hospital records who received routine clinical evaluation and management . The cohort includes patients who received one or more respiratory support modalities as part of usual care, including conventional oxygen therapy, high-flow nasal cannula oxygen therapy, noninvasive ventilation, and invasive mechanical ventilation. This is an observational study, and no intervention is assigned by the protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
the number of deaths in the hospitalized AECOPD patients
Measured: From study inclusion unitl death or up to 28 days of follow-up, whichever occurs first
Secondary outcomes (2)
ICU Length of stay
the total time when a patient is admitted to the ICU until they are discharged
Measured: From ICU admission until ICU discharge (transfer to a general ward or hospital discharge), assessed up to 90 days
Duration of (Invasive) Mechanical Ventilation
starts when a patient is connected to a ventilator and ends when ventilator is weaning
Measured: From initiation of invasive mechanical ventilation until discontinuation of ventilatory support (weaning completion), assesed up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start18 Mar 2026 (estimated)
- Primary completion18 Mar 2029 (estimated)
- Study completion18 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiqing Ge, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508943
- Sponsor's protocol ID
- 2026-0254
- Acronym
- OPTIVENT-COPD
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Davidson C, Banham S, Elliott M, Kennedy D, Gelder C, Glossop A, Church C, Creagh-Brown B, Dodd J, Felton T, Foex B, Mansfield L, McDonnell L, Parker R, Patterson C, Sovani M, Thomas L. British Thoracic Society/Intensive Care Society Guideline for the ventilatory management of acute hypercapnic respiratory failure in adults. BMJ Open Respir Res. 2016 Mar 14;3(1):e000133. doi: 10.1136/bmjresp-2016-000133. eCollection 2016. No abstract available.
PubMed 27026806Tan D, Wang B, Cao P, Wang Y, Sun J, Geng P, Walline JH, Wang Y, Wang C. High flow nasal cannula oxygen therapy versus non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease with acute-moderate hypercapnic respiratory failure: a randomized controlled non-inferiority trial. Crit Care. 2024 Jul 18;28(1):250. doi: 10.1186/s13054-024-05040-9.
PubMed 39026242Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.
PubMed 28860265Tan D, Walline JH, Ling B, Xu Y, Sun J, Wang B, Shan X, Wang Y, Cao P, Zhu Q, Geng P, Xu J. High-flow nasal cannula oxygen therapy versus non-invasive ventilation for chronic obstructive pulmonary disease patients after extubation: a multicenter, randomized controlled trial. Crit Care. 2020 Aug 6;24(1):489. doi: 10.1186/s13054-020-03214-9.
PubMed 32762701Li M, Wang F, Chen R, Liang Z, Zhou Y, Yang Y, Chen S, Ung COL, Hu H. Factors contributing to hospitalization costs for patients with COPD in China: a retrospective analysis of medical record data. Int J Chron Obstruct Pulmon Dis. 2018 Oct 12;13:3349-3357. doi: 10.2147/COPD.S175143. eCollection 2018.
PubMed 30349238Lin P, Shen C, Li Q, Huang Y, Zhou J, Lu Y, He A, Liu X, Luo M. A systematic review and meta-analysis of chronic obstructive pulmonary disease in asia: risk factors for readmission and readmission rate. BMC Pulm Med. 2024 Aug 12;24(1):388. doi: 10.1186/s12890-024-03203-6.
PubMed 39129020Hoogendoorn M, Hoogenveen RT, Rutten-van Molken MP, Vestbo J, Feenstra TL. Case fatality of COPD exacerbations: a meta-analysis and statistical modelling approach. Eur Respir J. 2011 Mar;37(3):508-15. doi: 10.1183/09031936.00043710. Epub 2010 Jul 1.
PubMed 20595157Wang Z, Lin J, Liang L, Huang F, Yao X, Peng K, Gao Y, Zheng J. Global, regional, and national burden of chronic obstructive pulmonary disease and its attributable risk factors from 1990 to 2021: an analysis for the Global Burden of Disease Study 2021. Respir Res. 2025 Jan 2;26(1):2. doi: 10.1186/s12931-024-03051-2.
PubMed 39748260
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision-making and Optimization of Ventilatory Support for AECOPD Patients
- ClinicalTrials.gov ID
- NCT07508943
- Acronym / sponsor ID
- OPTIVENT-COPD / 2026-0254
- Keywords
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Decision-Making, Real-World Data, Dynamic Programming, Respiratory Support
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 18 Mar 2026 (estimated)
- Primary completion
- 18 Mar 2029 (estimated)
- Study completion
- 18 Mar 2029 (estimated)
- First posted
- 2 Apr 2026 (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.
The goal of this retrospective observational study is to learn about how respiratory support is selected and adjusted in hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The main questions it aims to answer are:
- How are different respiratory support modalities selected for patients with AECOPD in real-world practice?
- What clinical patterns are associated with escalation, de-escalation, switching, or discontinuation of respiratory support during hospitalization? Researchers will review de-identified hospital records of patients admitted with AECOPD and analyze the dynamic use of respiratory support during hospitalization, including conventional oxygen therapy, high-flow nasal cannula oxygen therapy, non-invasive ventilation, and invasive mechanical ventilation.
Participants will not receive any study-assigned intervention. The study will use existing clinical data collected during routine inpatient care and will not change diagnosis, treatment, or follow-up.
Detailed description
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a major cause of hospitalization, respiratory failure, and poor clinical outcomes in patients with chronic obstructive pulmonary disease. Respiratory support is a key component of acute management and commonly includes conventional oxygen therapy (COT), high-flow nasal cannula oxygen therapy (HFNC), non-invasive ventilation (NIV), and invasive mechanical ventilation (IMV). In clinical practice, respiratory support decisions are not static; rather, they involve a dynamic and sequential process of initial selection, reassessment, escalation, de-escalation, switching, and withdrawal according to changes in patient condition. Inappropriate timing of escalation or unnecessary use of higher-intensity support may contribute to treatment failure and unfavorable outcomes.
This study is a retrospective observational study based on routinely collected clinical data from hospitalized patients with AECOPD. Using historical data extracted from hospital clinical information systems and electronic medical records, the study will systematically characterize respiratory support pathways during hospitalization and examine how support strategies are adjusted over time in response to changes in disease status. The study will not introduce any additional tests, procedures, or interventions, and will not alter prior or current clinical care.
The analytical framework of the study is based on sequential decision analysis. Patient condition will be reassessed at fixed time intervals during hospitalization using key physiological and monitoring parameters recorded in routine care. These indicators will be integrated into clinically interpretable disease-state strata, and each state will be linked to the respiratory support modality being used at that stage. The respiratory support decision at the subsequent stage will then be characterized as maintenance, escalation, de-escalation, switching, or discontinuation. Under clinically reasonable safety and feasibility constraints, retrospective data will be used to summarize the statistical patterns of disease evolution and outcomes associated with different respiratory support choices. Dynamic programming methods will be applied to explore interpretable sequential decision patterns aligned with relevant clinical goals, such as reducing treatment failure and intubation-related adverse outcomes, while avoiding unnecessary use of high-intensity support and excessive switching between modalities.
Data used in this study will be derived entirely from existing inpatient records and will include demographic and baseline information, disease- and hospitalization-related information, key physiological and monitoring indicators, respiratory support records, and outcome-related information such as treatment escalation, intubation, and in-hospital outcomes. All data will be retrospectively extracted and de-identified before analysis. Only authorized research personnel will have access to the study database. Study findings will be reported in aggregate form, and no personally identifiable information will be disclosed.
Because this study uses previously collected clinical data only, does not involve direct participant contact, and does not affect clinical management, a waiver of informed consent will be sought in accordance with institutional ethics requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AECOPD group | – | –Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) identified from historical hospital records who received routine clinical evaluation and management . The cohort includes patients who received one or more respiratory support modalities as part of usual care, including conventional oxygen therapy, high-flow nasal cannula oxygen therapy, noninvasive ventilation, and invasive mechanical ventilation. This is an observational study, and no intervention is assigned by the protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be selected retrospectively from hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease . The source population includes patients receiving routine inpatient care, with particular relevance to critically ill patients with high-quality intensive care data. Eligible participants will be identified from hospital clinical information systems and electronic medical records based on diagnosis, respiratory support records, and availability of dynamic clinical data collected during hospitalization.
Key inclusion criteria (4 listed)
- Hospitalized patients with a documented diagnosis of acute exacerbation of chronic obstructive pulmonary disease.
- Patients identified retrospectively from hospital records during the predefined study period.
- Patients who received at least one form of respiratory support during the index hospitalization, including conventional oxygen therapy, high-flow nasal cannula oxygen therapy, noninvasive ventilation, or invasive mechanical ventilation.
- Patients with available clinical records containing sufficient dynamic physiological, laboratory, and treatment-related data for retrospective analysis.
Key exclusion criteria (6 listed)
- Patients whose hospitalization was not primarily due to acute exacerbation of COPD, even if COPD was documented as a comorbidity.
- Patients with stable COPD and no evidence of acute exacerbation during the index hospitalization.
- Patients admitted primarily for other acute conditions, including but not limited to pneumonia without documented AECOPD, acute heart failure, pulmonary embolism, pneumothorax, asthma exacerbation, trauma, or postoperative care.
- Patients with insufficient documentation to confirm AECOPD as the primary reason for admission.
- Patients with incomplete clinical records preventing retrospective analysis.
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
Mortality
Time frame: From study inclusion unitl death or up to 28 days of follow-up, whichever occurs first
the number of deaths in the hospitalized AECOPD patients
2 secondary outcomes
ICU Length of stay
Time frame: From ICU admission until ICU discharge (transfer to a general ward or hospital discharge), assessed up to 90 days
Duration of (Invasive) Mechanical Ventilation
Time frame: From initiation of invasive mechanical ventilation until discontinuation of ventilatory support (weaning completion), assesed up to 28 days
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 2 Apr 2026.
- Background: PubMed 27026806Davidson C, Banham S, Elliott M, Kennedy D, Gelder C, Glossop A, Church C, Creagh-Brown B, Dodd J, Felton T, Foex B, Mansfield L, McDonnell L, Parker R, Patterson C, Sovani M, Thomas L. British Thoracic Society/Intensive Care Society Guideline for the ventilatory management of acute hypercapnic respiratory failure in adults. BMJ Open Respir Res. 2016 Mar 14;3(1):e000133. doi: 10.1136/bmjresp-2016-000133. eCollection 2016. No abstract available.
- Background: PubMed 39026242Tan D, Wang B, Cao P, Wang Y, Sun J, Geng P, Walline JH, Wang Y, Wang C. High flow nasal cannula oxygen therapy versus non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease with acute-moderate hypercapnic respiratory failure: a randomized controlled non-inferiority trial. Crit Care. 2024 Jul 18;28(1):250. doi: 10.1186/s13054-024-05040-9.
- Background: PubMed 28860265Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.
- Background: PubMed 32762701Tan D, Walline JH, Ling B, Xu Y, Sun J, Wang B, Shan X, Wang Y, Cao P, Zhu Q, Geng P, Xu J. High-flow nasal cannula oxygen therapy versus non-invasive ventilation for chronic obstructive pulmonary disease patients after extubation: a multicenter, randomized controlled trial. Crit Care. 2020 Aug 6;24(1):489. doi: 10.1186/s13054-020-03214-9.
- Background: PubMed 30349238Li M, Wang F, Chen R, Liang Z, Zhou Y, Yang Y, Chen S, Ung COL, Hu H. Factors contributing to hospitalization costs for patients with COPD in China: a retrospective analysis of medical record data. Int J Chron Obstruct Pulmon Dis. 2018 Oct 12;13:3349-3357. doi: 10.2147/COPD.S175143. eCollection 2018.
- Background: PubMed 39129020Lin P, Shen C, Li Q, Huang Y, Zhou J, Lu Y, He A, Liu X, Luo M. A systematic review and meta-analysis of chronic obstructive pulmonary disease in asia: risk factors for readmission and readmission rate. BMC Pulm Med. 2024 Aug 12;24(1):388. doi: 10.1186/s12890-024-03203-6.
- Background: PubMed 20595157Hoogendoorn M, Hoogenveen RT, Rutten-van Molken MP, Vestbo J, Feenstra TL. Case fatality of COPD exacerbations: a meta-analysis and statistical modelling approach. Eur Respir J. 2011 Mar;37(3):508-15. doi: 10.1183/09031936.00043710. Epub 2010 Jul 1.
- Background: PubMed 39748260Wang Z, Lin J, Liang L, Huang F, Yao X, Peng K, Gao Y, Zheng J. Global, regional, and national burden of chronic obstructive pulmonary disease and its attributable risk factors from 1990 to 2021: an analysis for the Global Burden of Disease Study 2021. Respir Res. 2025 Jan 2;26(1):2. doi: 10.1186/s12931-024-03051-2.
- Related InfoLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 Apr 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 China. 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 Huiqing Ge, PhD (+86 13588706787, gehq@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: From study inclusion unitl death or up to 28 days of follow-up, whichever occurs first). 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 NCT07508943, which also lists 8 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 Apr 2026.