COPDICoReNCT06652776
The Italian Registry of Patients With Chronic Obstructive Pulmonary Disease
An observational study of COPD and COPD Exacerbation Acute, run by University of Milan at 1 site in Italy.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a treatable but debilitating medical condition associated with persistent symptoms and chronic airflow obstruction. Despite the availability of multiple therapeutic options, COPD is the third leading cause of death worldwide and has a substantial socioeconomic impact. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, COPD Exacerbation Acute, Comorbid Chronic Lung Disease on Heart Failure
- What is being tested?
- Pharmacological treatment
- Type of treatment
- Pill or oral medicine
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 30 Sep 2024to 31 Dec 2035
- How long will I take part?
- 10 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with functionally confirmed COPD and a track medical record in the 12 months before enrollment
Who may be able to join
- established diagnosis of COPD (defined as age ≥ 40 years old, smoking history ≤ 20 pack years, postbronchodilator forced expiratory volume in one second to slow vital capacity ratio (FEV1/VC) ≤ the lower limit of normal (LLN) criteria.
Who cannot join
- Presence of current clinically significant asthma
- Diagnosis or clinically significant alternative respiratory diseases (such as interstitial lung disease or bronchiectasis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Luigi Sacco University Hospital, Division of Department of Biomedical and Clinical Sciences, University of Milan
Milan, Milan, 20157
About this study
Official title: The Italian COPD Registry. The DescribinG bUrden of COPD and Occurrence of mortaLity in a Cohort of Italian Patients
Chronic obstructive pulmonary disease (COPD) is a treatable but debilitating medical condition associated with persistent symptoms and chronic airflow obstruction. Despite the availability of multiple therapeutic options, COPD is the third leading cause of death worldwide and has a substantial socioeconomic impact.
The present real life study is aimed at describing the clinical and functional characteristics, treatment patterns, impact of exacerbations and comorbidities and their association with mortality in a large cohort of Italian patients with COPD.
Read the detailed description
The temporal relationship of observation period to time of participant enrollment will be both retrospective and prospective.
A digital dataset will be shared with the participating centers. The following variables, if available, will be collected.
Demographic and clinical variables:
- Age, sex, height, weight, BMI, waist circumference.
- Pneumonia episodes in the last 12 months and number of hospitalizations for pneumonia.
- Number of pulmonary rehabilitation cycles performed
- Vaccination status (Flu, SARS-CoV-2, pneumococcus, human respiratory syncytial virus, herpes zoster)
COPD characteristics:
- Date of COPD diagnosis.
- COPD exacerbations in the year before the index date (mild, moderate, severe exacerbations), hospitalizations and/or access to ICU.
- Type, dosages and duration of antibiotic and systemic corticosteroid treatments during exacerbations.
- Respiratory symptoms evaluated with mMRC and CAT
- Frequency and purulence of sputum, cough frequency
- Inhaled bronchodilator/corticosteroid therapy and type of device used, any treatment changes at index date or during follow up.
- Mucolytic agents (active molecules and dosage)
- Chronic use of azithromycin
- Therapy with roflumilast.
- Biological therapies (type of active molecules, duration, switch).
- Long-term oxygen therapy (FiO2, average flow), presence of tracheostomy and any invasive or non-invasive ventilatory support
Comorbidities:
- Concomitant respiratory diseases, history of exposure to risk factors, smoking history (active, former and non-smoker).
- Cardiovascular comorbidities and complications in the last 12 months before index date and during follow up
- Cardioactive pharmacological therapies
- Charlson score
- Other comorbidities
Biological and functional variables:
- Blood tests (RBC, Hb, hematocrit, MCV, PLT, WBC differential, CRP, glycemia, creatinine, uremia, NT-proBNP, cholesterol).
- Cardiopulmonary exercise test. The variables collected will include: VO2max, WR max, HRmax, VE max, VEmax, VE/VO2 ratio, PET CO2, O2 pulse, anaerobic threshold, A-a gradient. All values will be collected as absolute and as percentage of predicted values.
- Nocturnal oximetry: FiO2, T-90, mean SpO2, ODI.
- Polysomnography: type of support (e.g. CPAP or NIMV), FiO2, apnea-hypopnea index (AHI; obstructive, central, and mixed type), AI, oxygen desaturation index (ODI), T-90, Cheyne-Stokes respiration, snoring and body position during the exam.
- 6 minutes walking test: FiO2, distance walked in meters and predicted value, SpO2 at the beginning and end of the test, desaturation, if SpO2\<90, modified Borg dyspnea score at the beginning and end of the test.
- Gas exchange: SpO2, FiO2, Blood Gas Analysis (pH, PaO2, PaCO2, HCO3-, A-a gradient, FiO2, PaO2/FiO2)
- Lung function test pre- and post-bronchodilator: FVC, FEV1, FEV1/FVC, FEF 25-75, VC, IC, FEV1/VC. All values will be collected as absolute values, ratio and percentage of predicted values.
- Body plethysmography pre- and post-bronchodilator: TGV, RV, TLC, RV/TLC, IC/TLC, sRAW. All values will be collected as absolute values, ratio and percentage of predicted values
- Diffusion capacity of the lung for carbon monoxide: DLCO, KCO, VA, TLC/VA
- Fractional exhaled nitric oxide
- Chest imaging: radiography or CT scan, presence of emphysema (panlobular or centrolobular), bronchiectasis or interstitial lung disease.
- Ecocardiography: ejection fraction, pathological signs, PAPs, left ventricular hypertrophy and left atrial, right ventricular or left ventricular enlargement.
- Coronary angiography: if pathological for stenosis and number of involved vessels, PTCA or CABG.
All these items will be also valued during the follow up period, with an emphasis on COPD exacerbations and date and cause of death.
- Conditions
- COPD, COPD Exacerbation Acute, Comorbid Chronic Lung Disease on Heart Failure, Mortality, Cardiovascular Diseases, Cardiovascular Events
- Being tested
- Pharmacological treatment
- Keywords
- COPD, AECOPD, Mortality in AECOPD, COPD mortality risk factors, COPD prevalence, lung function, emphysema, chronic bronchitis, COPD hospitalization, heart failure, cardiovascular mortality, Bronchodilators, COPD therapy, triple therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases, Emphysema, Bronchitis, Chronic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacological treatmentOther
Pharmacological and non pharmacological treatments will be assessed and monitored during the retrospective and prospective phase, and will include:
- bronchodilators, inhaled steroids and their combinations
- mucolytics
- biologic therapies for COPD
- roflumilast
- pulmonary rehabilitation
Pharmacological treatmentOther
All pharmacological and non pharmacological treatments for COPD will be assessed and monitored during the retrospective and prospective phase of the study, and will include:
- inhaled bronchodilators (long term beta-2 agonists and cholinergic antagonists), inhaled corticosteroids and their combinations
- mucolytics
- biologics for COPD (monoclonal antibodies)
- roflumilast
- chronic oral azythromicin
- pulmonary rehabilitation
- oxygen therapy
- non invasive/invasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | All patients with a functionally confirmed diagnosis of COPD Receives: Other: Pharmacological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Annual all-cause mortality rate
Measured: From index date (registry inclusion) until the date of death from any cause, assessed up to 120 months
Burden of moderate and severe COPD acute exacerbations
Incidence and annual rate of moderate and/or severe exacerbations
Measured: From index date (registry inclusion) until the date of first event of moderate or severe exacerbation, and any following event of moderate or severe exacerbation, or patient's death, whichever comes first, assessed up to 120 months
Secondary outcomes (6)
Cardiovascular mortality
Annual death rate for cardiovascular events
Measured: From index date (registry inclusion) until the date of death provoked by a cardiovascular event, assessed up to 120 months
Cardiovascular comorbidities
prevalence of cardiovascular comorbidities and their relationship with lung function, respiratory symptoms, moderate and severe exacerbations, mortality
Measured: At index date (registry inclusion) comorbidities will be registered and updated at every new visit until patient's death
Cardiovascular events
Incidence and prevalence of cardiovascular events (overall and severe) and their relationship with COPD acute exacerbations
Measured: From index date (registry inclusion) until the date of any cardiovascular event or cardiovascular death, whichever comes first, assessed up to 120 months
Lung function decline
trend in lung function indexes (spirometric, plethysmographic, DLCO) over time
Measured: From index date (registry inclusion) until the date of the first lung function test, and any following available lung function assessment, or the date of patient's death, whichever comes first, assessed up to 120 months
Eosinophil count
Describe eosinophil count in absolute and % of leukocyte formula in the study population, its trend over time and its relationship with lung function, lung function decline, COPD exacerbations, cardiovascular events and mortality
Measured: From index date (registry inclusion) until the date of first available eosinophil count, and any following point in time with available eosinophil count updates, or patients' death, whichever comes first, assessed up to 120 months
Evaluation of the pharmacological treatment at baseline and treatment switches
Prevalence of type of inhaled therapy over time from index date until end of study
Measured: From index date (registry inclusion) until the date of first available inhaled treatment switch, and every point in time the patient changes inhaled treatment, or the patient's death from any cause, whichever comes first, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start30 Sep 2024
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Other
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Genova, University of Pavia, Azienda Ospedaliera Universitaria Integrata Verona, University Magna Graecia, University of Rome Tor Vergata, Università degli Studi di Sassari, University of Palermo, University of Turin, Italy, University Hospital Verona, Italy, University Hospital of Ferrara, Societa Italiana di Pneumologia, Italian Association of Hospital Pneumologists
- Responsible party
- Principal investigator, Pierachille Santus, MD, PhD, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652776
- Sponsor's protocol ID
- 20-27Sept2023
- Acronym
- ICoRe
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Santus P, Di Marco F, Braido F, Contoli M, Corsico AG, Micheletto C, Pelaia G, Radovanovic D, Rogliani P, Saderi L, Scichilone N, Tanzi S, Vella M, Boarino S, Sotgiu G, Solidoro P. Exacerbation Burden in COPD and Occurrence of Mortality in a Cohort of Italian Patients: Results of the Gulp Study. Int J Chron Obstruct Pulmon Dis. 2024 Mar 1;19:607-618. doi: 10.2147/COPD.S446636. eCollection 2024.
PubMed 38444551Radovanovic D, Contoli M, Marco FD, Sotgiu G, Pelaia G, Braido F, Corsico AG, Micheletto C, Rogliani P, Scichilone N, Saderi L, Santus P, Solidoro P. Clinical and Functional Characteristics of COPD Patients Across GOLD Classifications: Results of a Multicenter Observational Study. COPD. 2019 Aug;16(3-4):215-226. doi: 10.1080/15412555.2019.1659760. Epub 2019 Sep 9.
PubMed 31500459
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Italian COPD Registry. The DescribinG bUrden of COPD and Occurrence of mortaLity in a Cohort of Italian Patients
- ClinicalTrials.gov ID
- NCT06652776
- Acronym / sponsor ID
- ICoRe / 20-27Sept2023
- Conditions
- COPD, COPD Exacerbation Acute, Comorbid Chronic Lung Disease on Heart Failure, Mortality, Cardiovascular Diseases, Cardiovascular Events
- Keywords
- COPD, AECOPD, Mortality in AECOPD, COPD mortality risk factors, COPD prevalence, lung function, emphysema, chronic bronchitis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- University of Genova, University of Pavia, Azienda Ospedaliera Universitaria Integrata Verona, University Magna Graecia, University of Rome Tor Vergata, Università degli Studi di Sassari, University of Palermo, University of Turin, Italy, University Hospital Verona, Italy, University Hospital of Ferrara, Societa Italiana di Pneumologia, Italian Association of Hospital Pneumologists
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic obstructive pulmonary disease (COPD) is a treatable but debilitating medical condition associated with persistent symptoms and chronic airflow obstruction. Despite the availability of multiple therapeutic options, COPD is the third leading cause of death worldwide and has a substantial socioeconomic impact.
The present real life study is aimed at describing the clinical and functional characteristics, treatment patterns, impact of exacerbations and comorbidities and their association with mortality in a large cohort of Italian patients with COPD.
Detailed description
The temporal relationship of observation period to time of participant enrollment will be both retrospective and prospective.
A digital dataset will be shared with the participating centers. The following variables, if available, will be collected.
Demographic and clinical variables:
- Age, sex, height, weight, BMI, waist circumference.
- Pneumonia episodes in the last 12 months and number of hospitalizations for pneumonia.
- Number of pulmonary rehabilitation cycles performed
- Vaccination status (Flu, SARS-CoV-2, pneumococcus, human respiratory syncytial virus, herpes zoster)
COPD characteristics:
- Date of COPD diagnosis.
- COPD exacerbations in the year before the index date (mild, moderate, severe exacerbations), hospitalizations and/or access to ICU.
- Type, dosages and duration of antibiotic and systemic corticosteroid treatments during exacerbations.
- Respiratory symptoms evaluated with mMRC and CAT
- Frequency and purulence of sputum, cough frequency
- Inhaled bronchodilator/corticosteroid therapy and type of device used, any treatment changes at index date or during follow up.
- Mucolytic agents (active molecules and dosage)
- Chronic use of azithromycin
- Therapy with roflumilast.
- Biological therapies (type of active molecules, duration, switch).
- Long-term oxygen therapy (FiO2, average flow), presence of tracheostomy and any invasive or non-invasive ventilatory support
Comorbidities:
- Concomitant respiratory diseases, history of exposure to risk factors, smoking history (active, former and non-smoker).
- Cardiovascular comorbidities and complications in the last 12 months before index date and during follow up
- Cardioactive pharmacological therapies
- Charlson score
- Other comorbidities
Biological and functional variables:
- Blood tests (RBC, Hb, hematocrit, MCV, PLT, WBC differential, CRP, glycemia, creatinine, uremia, NT-proBNP, cholesterol).
- Cardiopulmonary exercise test. The variables collected will include: VO2max, WR max, HRmax, VE max, VEmax, VE/VO2 ratio, PET CO2, O2 pulse, anaerobic threshold, A-a gradient. All values will be collected as absolute and as percentage of predicted values.
- Nocturnal oximetry: FiO2, T-90, mean SpO2, ODI.
- Polysomnography: type of support (e.g. CPAP or NIMV), FiO2, apnea-hypopnea index (AHI; obstructive, central, and mixed type), AI, oxygen desaturation index (ODI), T-90, Cheyne-Stokes respiration, snoring and body position during the exam.
- 6 minutes walking test: FiO2, distance walked in meters and predicted value, SpO2 at the beginning and end of the test, desaturation, if SpO2\<90, modified Borg dyspnea score at the beginning and end of the test.
- Gas exchange: SpO2, FiO2, Blood Gas Analysis (pH, PaO2, PaCO2, HCO3-, A-a gradient, FiO2, PaO2/FiO2)
- Lung function test pre- and post-bronchodilator: FVC, FEV1, FEV1/FVC, FEF 25-75, VC, IC, FEV1/VC. All values will be collected as absolute values, ratio and percentage of predicted values.
- Body plethysmography pre- and post-bronchodilator: TGV, RV, TLC, RV/TLC, IC/TLC, sRAW. All values will be collected as absolute values, ratio and percentage of predicted values
- Diffusion capacity of the lung for carbon monoxide: DLCO, KCO, VA, TLC/VA
- Fractional exhaled nitric oxide
- Chest imaging: radiography or CT scan, presence of emphysema (panlobular or centrolobular), bronchiectasis or interstitial lung disease.
- Ecocardiography: ejection fraction, pathological signs, PAPs, left ventricular hypertrophy and left atrial, right ventricular or left ventricular enlargement.
- Coronary angiography: if pathological for stenosis and number of involved vessels, PTCA or CABG.
All these items will be also valued during the follow up period, with an emphasis on COPD exacerbations and date and cause of death.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | Other: Pharmacological treatmentAll patients with a functionally confirmed diagnosis of COPD |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with functionally confirmed COPD and a track medical record in the 12 months before enrollment
Key inclusion criteria (1 listed)
- established diagnosis of COPD (defined as age ≥ 40 years old, smoking history ≤ 20 pack years, postbronchodilator forced expiratory volume in one second to slow vital capacity ratio (FEV1/VC) ≤ the lower limit of normal (LLN) criteria.
Key exclusion criteria (2 listed)
- Presence of current clinically significant asthma
- Diagnosis or clinically significant alternative respiratory diseases (such as interstitial lung disease or bronchiectasis)
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 |
|---|---|---|
| Pharmacological treatmentPharmacological and non pharmacological treatments will be assessed and monitored during the retrospective and prospective phase, and will include: * bronchodilators, inhaled steroids and their combinations * mucolytics * biologic therapies for COPD * roflumilast * pulmonary rehabilitation | Other | COPD patients |
| Pharmacological treatmentAll pharmacological and non pharmacological treatments for COPD will be assessed and monitored during the retrospective and prospective phase of the study, and will include: * inhaled bronchodilators (long term beta-2 agonists and cholinergic antagonists), inhaled corticosteroids and their combinations * mucolytics * biologics for COPD (monoclonal antibodies) * roflumilast * chronic oral azythromicin * pulmonary rehabilitation * oxygen therapy * non invasive/invasive ventilation | Other | COPD patients |
Primary outcome
All cause mortality
Time frame: From index date (registry inclusion) until the date of death from any cause, assessed up to 120 months
Annual all-cause mortality rate
Burden of moderate and severe COPD acute exacerbations
Time frame: From index date (registry inclusion) until the date of first event of moderate or severe exacerbation, and any following event of moderate or severe exacerbation, or patient's death, whichever comes first, assessed up to 120 months
Incidence and annual rate of moderate and/or severe exacerbations
6 secondary outcomes
Cardiovascular mortality
Time frame: From index date (registry inclusion) until the date of death provoked by a cardiovascular event, assessed up to 120 months
Cardiovascular comorbidities
Time frame: At index date (registry inclusion) comorbidities will be registered and updated at every new visit until patient's death
Cardiovascular events
Time frame: From index date (registry inclusion) until the date of any cardiovascular event or cardiovascular death, whichever comes first, assessed up to 120 months
Lung function decline
Time frame: From index date (registry inclusion) until the date of the first lung function test, and any following available lung function assessment, or the date of patient's death, whichever comes first, assessed up to 120 months
Eosinophil count
Time frame: From index date (registry inclusion) until the date of first available eosinophil count, and any following point in time with available eosinophil count updates, or patients' death, whichever comes first, assessed up to 120 months
Evaluation of the pharmacological treatment at baseline and treatment switches
Time frame: From index date (registry inclusion) until the date of first available inhaled treatment switch, and every point in time the patient changes inhaled treatment, or the patient's death from any cause, whichever comes first, assessed up to 120 months
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 4 May 2026.
- Background: PubMed 38444551Santus P, Di Marco F, Braido F, Contoli M, Corsico AG, Micheletto C, Pelaia G, Radovanovic D, Rogliani P, Saderi L, Scichilone N, Tanzi S, Vella M, Boarino S, Sotgiu G, Solidoro P. Exacerbation Burden in COPD and Occurrence of Mortality in a Cohort of Italian Patients: Results of the Gulp Study. Int J Chron Obstruct Pulmon Dis. 2024 Mar 1;19:607-618. doi: 10.2147/COPD.S446636. eCollection 2024.
- Background: PubMed 31500459Radovanovic D, Contoli M, Marco FD, Sotgiu G, Pelaia G, Braido F, Corsico AG, Micheletto C, Rogliani P, Scichilone N, Saderi L, Santus P, Solidoro P. Clinical and Functional Characteristics of COPD Patients Across GOLD Classifications: Results of a Multicenter Observational Study. COPD. 2019 Aug;16(3-4):215-226. doi: 10.1080/15412555.2019.1659760. Epub 2019 Sep 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COPD and COPD Exacerbation Acute, run by University of Milan at 1 site in Italy.
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 1 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 4 May 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 Italy. 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?
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?
All cause mortality (time frame: From index date (registry inclusion) until the date of death from any cause, assessed up to 120 months). The study lists 2 primary outcomes in all. 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 NCT06652776, which also lists 2 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 4 May 2026.