Severe Chronic Obstructive Pulmonary DiseaseSPOCCATNCT06252805

Severe Prospective Observational COPD Catalonia

An observational study of Severe Chronic Obstructive Pulmonary Disease, run by Ferran Morell.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

Multicenter observational study to characterize and follow-up a cohort of patients with severe chronic obstructive pulmonary disease (COPD) in Catalonia Read more about this study

Who is it for?: Ages 35 years and older
Conditions the study is for: Severe Chronic Obstructive Pulmonary Disease
How many people: 450 participants
Where: No sites listed yet
Study dates: 10 Mar 2024to 31 Mar 2030
How long will I take part?: 5 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 35 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: COPD subjects from respiratory departments in Hospitals from Catalonia

Who may be able to join

Informed consent: a signed and dated written informed consent prior to study participation
Age: Subjects 35 years of age or order at visit 1.
Severe COPD diagnosis: an established severe COPD defined by spirometry values:
A post-albuterol/salbutamol FEV1/FVC ratio of <0.70 at visit 1. FEV1: forced expiratory volume at one second FVC: forced vital capacity.
A post-bronchodilator FEV1 < 50% predicted normal
Smoking history: ≥ 10 pack-years at visit 1
Stable phase of the disease (not less than 4 weeks of stability prior visit 1)

Who cannot join

Subjects not giving written informed consent.
Subjects at risk of non-compliance, or unable to comply with the scheduled visits.
Subjects affected mainly by another severe chronic respiratory disease that justifies the ventilatory alteration, for example pulmonary fibrosis or severe bronchiectasis
Subjects with carcinoma that has not been in complete remission for at least 5 years.
Subjects with α1-antitrypsin deficiency as the underlying cause of COPD

About this study

Official title: Severe Prospective Observational Study of COPD in Catalonia

Multicenter observational study to characterize and follow-up a cohort of patients with severe chronic obstructive pulmonary disease (COPD) in Catalonia

Read the detailed description

Creation of the first multicenter observational study in Catalonia to characterize and follow-up of patients with severe chronic obstructive pulmonary disease. The follow-up will be up to 5 years, with a first initial visit and control visits every year. All patients will be recruited from respiratory departments from major hospitals from Catalonia, a region with approximately 8 million inhabitants and a wide web of public hospitals.

Conditions: Severe Chronic Obstructive Pulmonary Disease
Keywords: Severe COPD, Cohort, Catalonia, Prospective, Multicenter, 5 year follow-up, characterisation, COPD comorbidities, COPD phenotypes
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06252805
Study group	Role	What they receive
SPOCCAT		Severe Chronic Obstructive Pulmonary Disease patients in Catalonia

What is being measured

The primary outcome is the main question the study is designed to answer.

Cohort creation in Catalonia
Creation of a long follow-up (5 years) cohort of severe COPD patients in Catalonia
Measured: Up to 5 years
Describe the demographic and clinical characteristics of patients with severe COPD in Catalonia.
Identify the distribution of sex, age, severity of lung function impairment, treatment administered and comorbidities of severe COPD patients
Measured: Up to 5 years
Assess the natural history and prognosis of severe COPD
Assess the decline in lung function, frequency and severity of exacerbations and survival over a period of 5 years
Measured: Up to 5 years

Secondary outcomes (3)

Assess effect of the different treatments, both inhaled and non-inhaled, on the disease progression and according to the patient's phenotype.
Compare the evolution in terms of decline in lung function, exacerbations and survival in patients treated with inhaled corticosteroids versus patients treated without inhaled corticosteroids
Measured: Up to 5 years
Impact of exacerbations and chronic bronchial infection on the evolution of COPD
Compare the evolution in terms of decline in lung function, frequency and severity of exacerbations and survival according to the presence and severity of exacerbations and the presence of chronic bronchial infection during follow-up
Measured: Up to 5 years
Importance of comorbidities in the evolution of COPD
Compare the evolution in terms of decline in lung function, frequency and severity of exacerbations and survival according to the presence and severity of different comorbidities and according to the scores on the Chrlson comorbidity index
Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 202431 Mar 2030

First posted12 Feb 2024
Study start10 Mar 2024 (estimated)
Primary completion31 Mar 2025 (estimated)
Study completion31 Mar 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Severe Chronic Obstructive Pulmonary DiseaseStudies 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: 450 participants (estimated)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT06252805
Sponsor's protocol ID: FUC-SPOCCAT-2023-10
Acronym: SPOCCAT
Status last verified: Feb 2024
First submitted: 2 Oct 2023
Last updated: 12 Feb 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.
PubMed 14999112
Almagro P, Soriano JB, Cabrera FJ, Boixeda R, Alonso-Ortiz MB, Barreiro B, Diez-Manglano J, Murio C, Heredia JL; Working Group on COPD, SpanishSociety of Internal Medicine*. Short- and medium-term prognosis in patients hospitalized for COPD exacerbation: the CODEX index. Chest. 2014 May;145(5):972-980. doi: 10.1378/chest.13-1328.
PubMed 24077342
Fletcher C, Peto R. The natural history of chronic airflow obstruction. Br Med J. 1977 Jun 25;1(6077):1645-8. doi: 10.1136/bmj.1.6077.1645.
PubMed 871704
Lokke A, Lange P, Scharling H, Fabricius P, Vestbo J. Developing COPD: a 25 year follow up study of the general population. Thorax. 2006 Nov;61(11):935-9. doi: 10.1136/thx.2006.062802.
PubMed 17071833
Kohansal R, Martinez-Camblor P, Agusti A, Buist AS, Mannino DM, Soriano JB. The natural history of chronic airflow obstruction revisited: an analysis of the Framingham offspring cohort. Am J Respir Crit Care Med. 2009 Jul 1;180(1):3-10. doi: 10.1164/rccm.200901-0047OC. Epub 2009 Apr 2.
PubMed 19342411
Vestbo J, Anderson W, Coxson HO, Crim C, Dawber F, Edwards L, Hagan G, Knobil K, Lomas DA, MacNee W, Silverman EK, Tal-Singer R; ECLIPSE investigators. Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE). Eur Respir J. 2008 Apr;31(4):869-73. doi: 10.1183/09031936.00111707. Epub 2008 Jan 23.
PubMed 18216052
Garcia-Aymerich J, Gomez FP, Anto JM; en nombre del Grupo Investigador del Estudio PAC-COPD. [Phenotypic characterization and course of chronic obstructive pulmonary disease in the PAC-COPD Study: design and methods]. Arch Bronconeumol. 2009 Jan;45(1):4-11. doi: 10.1016/j.arbres.2008.03.001. Epub 2009 Jan 3. Spanish.
PubMed 19186292
Regan EA, Hokanson JE, Murphy JR, Make B, Lynch DA, Beaty TH, Curran-Everett D, Silverman EK, Crapo JD. Genetic epidemiology of COPD (COPDGene) study design. COPD. 2010 Feb;7(1):32-43. doi: 10.3109/15412550903499522.
PubMed 20214461
Makita H, Nasuhara Y, Nagai K, Ito Y, Hasegawa M, Betsuyaku T, Onodera Y, Hizawa N, Nishimura M; Hokkaido COPD Cohort Study Group. Characterisation of phenotypes based on severity of emphysema in chronic obstructive pulmonary disease. Thorax. 2007 Nov;62(11):932-7. doi: 10.1136/thx.2006.072777. Epub 2007 Jun 15.
PubMed 17573447
Kunzli N, Ackermann-Liebrich U, Keller R, Perruchoud AP, Schindler C. Variability of FVC and FEV1 due to technician, team, device and subject in an eight centre study: three quality control studies in SAPALDIA. Swiss Study on Air Pollution and Lung Disease in Adults. Eur Respir J. 1995 Mar;8(3):371-6. doi: 10.1183/09031936.95.08030371.
PubMed 7789479
Downs SH, Brandli O, Zellweger JP, Schindler C, Kunzli N, Gerbase MW, Burdet L, Bettschart R, Zemp E, Frey M, Keller R, Tschopp JM, Leuenberger P, Ackermann-Liebrich U; SAPALDIA team. Accelerated decline in lung function in smoking women with airway obstruction: SAPALDIA 2 cohort study. Respir Res. 2005 May 26;6(1):45. doi: 10.1186/1465-9921-6-45.
PubMed 15918902
Lopez-Campos JL, Peces-Barba G, Soler-Cataluna JJ, Soriano JB, de Lucas Ramos P, de-Torres JP, Marin JM, Casanova C; en nombre del grupo de estudio CHAIN. Chronic obstructive pulmonary disease history assessment in Spain: a multidimensional chronic obstructive pulmonary disease evaluation. Study methods and organization. Arch Bronconeumol. 2012 Dec;48(12):453-9. doi: 10.1016/j.arbres.2012.05.006. Epub 2012 Jul 4. English, Spanish.
PubMed 22766419
Calle Rubio M, Rodriguez Hermosa JL, de Torres JP, Marin JM, Martinez-Gonzalez C, Fuster A, Cosio BG, Peces-Barba G, Solanes I, Feu-Collado N, Lopez-Campos JL, Casanova C; CHAIN Study Investigators. COPD Clinical Control: predictors and long-term follow-up of the CHAIN cohort. Respir Res. 2021 Feb 4;22(1):36. doi: 10.1186/s12931-021-01633-y.
PubMed 33541356
Chen CZ, Shih CY, Hsiue TR, Tsai SH, Liao XM, Yu CH, Yang SC, Wang JD. Life expectancy (LE) and loss-of-LE for patients with chronic obstructive pulmonary disease. Respir Med. 2020 Oct;172:106132. doi: 10.1016/j.rmed.2020.106132. Epub 2020 Aug 29.
PubMed 32905891
Soriano JB, Alfageme I, Miravitlles M, de Lucas P, Soler-Cataluna JJ, Garcia-Rio F, Casanova C, Rodriguez Gonzalez-Moro JM, Cosio BG, Sanchez G, Ancochea J. Prevalence and Determinants of COPD in Spain: EPISCAN II. Arch Bronconeumol (Engl Ed). 2021 Jan;57(1):61-69. doi: 10.1016/j.arbres.2020.07.024. Epub 2020 Sep 17. English, Spanish.
PubMed 32950310

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-1)
Pulmonary Disease, Chronic Obstructive
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-2)
Pulmonary Disease, Chronic Obstructive
Not yet recruitingPhase 2
A Study to Assess the Efficacy and Safety of Co-administration of GSK3862995B With GSK5784283 in Adult Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive

All Severe Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Severe Prospective Observational Study of COPD in Catalonia
ClinicalTrials.gov ID: NCT06252805
Acronym / sponsor ID: SPOCCAT / FUC-SPOCCAT-2023-10
Conditions: Severe Chronic Obstructive Pulmonary Disease
Keywords: Severe COPD, Cohort, Catalonia, Prospective, Multicenter, 5 year follow-up, characterisation, COPD comorbidities
Study type: Observational
Recruitment status: Not yet recruiting
Enrolment: 450 participants (estimated)
Lead sponsor: Ferran MorellUniversity, hospital or other
Study start: 10 Mar 2024 (estimated)
Primary completion: 31 Mar 2025 (estimated)
Study completion: 31 Mar 2030 (estimated)
First posted: 12 Feb 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.

Multicenter observational study to characterize and follow-up a cohort of patients with severe chronic obstructive pulmonary disease (COPD) in Catalonia

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 5 Years
Number of arms: 1

Arm	Type	Receives
SPOCCAT	–	–Severe Chronic Obstructive Pulmonary Disease patients in Catalonia

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: COPD subjects from respiratory departments in Hospitals from Catalonia

Key inclusion criteria (7 listed)

Informed consent: a signed and dated written informed consent prior to study participation
Age: Subjects 35 years of age or order at visit 1.
Severe COPD diagnosis: an established severe COPD defined by spirometry values:
Smoking history: ≥ 10 pack-years at visit 1
Stable phase of the disease (not less than 4 weeks of stability prior visit 1)

Key exclusion criteria (5 listed)

Subjects not giving written informed consent.
Subjects at risk of non-compliance, or unable to comply with the scheduled visits.
Subjects affected mainly by another severe chronic respiratory disease that justifies the ventilatory alteration, for example pulmonary fibrosis or severe bronchiectasis
Subjects with carcinoma that has not been in complete remission for at least 5 years.
Subjects with α1-antitrypsin deficiency as the underlying cause of COPD

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

Cohort creation in Catalonia
Time frame: Up to 5 years
Creation of a long follow-up (5 years) cohort of severe COPD patients in Catalonia
Describe the demographic and clinical characteristics of patients with severe COPD in Catalonia.
Time frame: Up to 5 years
Identify the distribution of sex, age, severity of lung function impairment, treatment administered and comorbidities of severe COPD patients
Assess the natural history and prognosis of severe COPD
Time frame: Up to 5 years
Assess the decline in lung function, frequency and severity of exacerbations and survival over a period of 5 years

3 secondary outcomes

Assess effect of the different treatments, both inhaled and non-inhaled, on the disease progression and according to the patient's phenotype.
Time frame: Up to 5 years
Impact of exacerbations and chronic bronchial infection on the evolution of COPD
Time frame: Up to 5 years
Importance of comorbidities in the evolution of COPD
Time frame: Up to 5 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 Feb 2024.
Background: PubMed 14999112Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.
Background: PubMed 24077342Almagro P, Soriano JB, Cabrera FJ, Boixeda R, Alonso-Ortiz MB, Barreiro B, Diez-Manglano J, Murio C, Heredia JL; Working Group on COPD, SpanishSociety of Internal Medicine*. Short- and medium-term prognosis in patients hospitalized for COPD exacerbation: the CODEX index. Chest. 2014 May;145(5):972-980. doi: 10.1378/chest.13-1328.
Background: PubMed 871704Fletcher C, Peto R. The natural history of chronic airflow obstruction. Br Med J. 1977 Jun 25;1(6077):1645-8. doi: 10.1136/bmj.1.6077.1645.
Background: PubMed 17071833Lokke A, Lange P, Scharling H, Fabricius P, Vestbo J. Developing COPD: a 25 year follow up study of the general population. Thorax. 2006 Nov;61(11):935-9. doi: 10.1136/thx.2006.062802.
Background: PubMed 19342411Kohansal R, Martinez-Camblor P, Agusti A, Buist AS, Mannino DM, Soriano JB. The natural history of chronic airflow obstruction revisited: an analysis of the Framingham offspring cohort. Am J Respir Crit Care Med. 2009 Jul 1;180(1):3-10. doi: 10.1164/rccm.200901-0047OC. Epub 2009 Apr 2.
Background: PubMed 18216052Vestbo J, Anderson W, Coxson HO, Crim C, Dawber F, Edwards L, Hagan G, Knobil K, Lomas DA, MacNee W, Silverman EK, Tal-Singer R; ECLIPSE investigators. Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE). Eur Respir J. 2008 Apr;31(4):869-73. doi: 10.1183/09031936.00111707. Epub 2008 Jan 23.
Background: PubMed 19186292Garcia-Aymerich J, Gomez FP, Anto JM; en nombre del Grupo Investigador del Estudio PAC-COPD. [Phenotypic characterization and course of chronic obstructive pulmonary disease in the PAC-COPD Study: design and methods]. Arch Bronconeumol. 2009 Jan;45(1):4-11. doi: 10.1016/j.arbres.2008.03.001. Epub 2009 Jan 3. Spanish.
Background: PubMed 20214461Regan EA, Hokanson JE, Murphy JR, Make B, Lynch DA, Beaty TH, Curran-Everett D, Silverman EK, Crapo JD. Genetic epidemiology of COPD (COPDGene) study design. COPD. 2010 Feb;7(1):32-43. doi: 10.3109/15412550903499522.
Background: PubMed 17573447Makita H, Nasuhara Y, Nagai K, Ito Y, Hasegawa M, Betsuyaku T, Onodera Y, Hizawa N, Nishimura M; Hokkaido COPD Cohort Study Group. Characterisation of phenotypes based on severity of emphysema in chronic obstructive pulmonary disease. Thorax. 2007 Nov;62(11):932-7. doi: 10.1136/thx.2006.072777. Epub 2007 Jun 15.
Background: PubMed 7789479Kunzli N, Ackermann-Liebrich U, Keller R, Perruchoud AP, Schindler C. Variability of FVC and FEV1 due to technician, team, device and subject in an eight centre study: three quality control studies in SAPALDIA. Swiss Study on Air Pollution and Lung Disease in Adults. Eur Respir J. 1995 Mar;8(3):371-6. doi: 10.1183/09031936.95.08030371.
Background: PubMed 15918902Downs SH, Brandli O, Zellweger JP, Schindler C, Kunzli N, Gerbase MW, Burdet L, Bettschart R, Zemp E, Frey M, Keller R, Tschopp JM, Leuenberger P, Ackermann-Liebrich U; SAPALDIA team. Accelerated decline in lung function in smoking women with airway obstruction: SAPALDIA 2 cohort study. Respir Res. 2005 May 26;6(1):45. doi: 10.1186/1465-9921-6-45.
Background: PubMed 22766419Lopez-Campos JL, Peces-Barba G, Soler-Cataluna JJ, Soriano JB, de Lucas Ramos P, de-Torres JP, Marin JM, Casanova C; en nombre del grupo de estudio CHAIN. Chronic obstructive pulmonary disease history assessment in Spain: a multidimensional chronic obstructive pulmonary disease evaluation. Study methods and organization. Arch Bronconeumol. 2012 Dec;48(12):453-9. doi: 10.1016/j.arbres.2012.05.006. Epub 2012 Jul 4. English, Spanish.
GOLD COPD 2023 report (GOLD: Global Initiative for Chronical Obstructive Lung Disease)Link provided by the sponsor.
WHO (World Health Organization). The Top 10 causes ofr deathLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Severe Chronic Obstructive Pulmonary Disease

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-1)
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RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-2)
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Not yet recruitingPhase 2
A Study to Assess the Efficacy and Safety of Co-administration of GSK3862995B With GSK5784283 in Adult Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive

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.

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Chronic Obstructive Pulmonary Disease, run by Ferran Morell.

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 7 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: opening soon, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Cohort creation in Catalonia (time frame: Up to 5 years). The study lists 3 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 NCT06252805, which also lists 15 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 12 Feb 2024.