An observational study in Chronic Obstructive Pulmonary Disease (COPD) and Asthma, sponsored by AstraZeneca. Recruiting at 10 sites in South Korea. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by AstraZeneca · Observational
Among 240 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca — 14 open to participants now, 15 under way, 4 of them phase 3. Pulmonary Disease, Chronic Obstructive · AstraZeneca.
Among the 240 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, this one is the 60th largest by planned enrollment of the 86 observational ones that give a count, is one of 3 that started in 2026, is one of 87 observational ones, reaches primary completion later than 6 of the 14 other live ones, and was the 240th registered.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →14 of the 240 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in France
AstraZeneca · Sites in India
AstraZeneca · Sites in Argentina, Egypt, Mexico and 4 more countries
AstraZeneca · Sites in Argentina, Colombia, Egypt and 9 more countries
AstraZeneca · Sites in Russia
By country, each count listing its studies:
Of the 555 Pulmonary Disease, Chronic Obstructive studies recruiting now, 305 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 87 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
240 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 34 · Phase 2 42 · Phase 3 59 · Phase 4 19
First in 1999; this study’s year is marked. 3 started in 2026.
This study's planned enrollment of 600 is above the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 150 across the 153 interventional studies, 1,008 across the 86 observational. Of the 222 that completed or were terminated, 95 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
9 of the studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06712563AstraZenecaPooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting | 2026-12-14 |
| NCT07245576AstraZenecaAssess Accuracy of Primary Care Asthma and COPD Diagnosis Using Oscillometry and FeNO vs Specialist Diagnosis | 2027-04-30 |
| NCT07315958AstraZenecaStudy for Assessing the Prevalence of Airflow Limitation in Outpatients With History of Smoking Attending Cardiology Clinics | 2027-04-30 |
| NCT07073950AstraZenecaA Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation | 2027-05-31 |
| NCT07307781AstraZenecaStudy of Patient With Frequent Exacerbations in Moscow | 2027-06-25 |
Among the 240 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
As part of a post-approval commitment requested by the Ministry of Food and Drug Safety (MFDS), this open-label, single-arm, multicentre, observational Post-Marketing Surveillance (PMS) study aims to characterize the safety profile of Breztri in real-world clinical practice settings, either confirming known safety outcomes or identifying previously unsuspected adverse drug reactions. The study will also evaluate effectiveness of Breztri in real-world clinical practice settings, generating essential clinical evidence from a broader and more diverse Korean patient population representative of daily medical practice.
This is an open-label, primary data collection, single-arm, multicentre, observational study. Eligible patients who initiate treatment with Breztri according to approved indications will be enrolled after obtaining informed consent. All patients treated (minimum 600 patients required) with Breztri in accordance with the local prescribing information are eligible for enrolment in this study. Initiation or continuation of Breztri prescription and patient enrolment will depend on physicians' medical decisions as per routine clinical practice. Approximately 30 study sites are expected to participate in this study.
As this study will be performed under clinical practice, the investigator may prescribe any other concomitant medications that are necessary for the patient as locally approved.
The total number of visits and the visit time will be determined at the discretion of the investigator based on the patient's condition.
Patients will be observed for up to 24 weeks. Follow-up will begin on the date of the first administration of Breztri (index date). However, if a patient is found to meet any of the exclusion criteria after enrolment, no additional follow-up (including the 30-day safety follow-up) will be conducted.
The primary objective of this study is to characterize the safety profile separately in patients with COPD and in patients with asthma receiving Breztri under the approved indication(s) in Korea over a 24-week follow-up period, or until the end of treatment (EoT) if discontinued earlier.
The secondary objective of this study is to describe changes in clinical outcomes from baseline to week 12 and week 24, separately in patients with COPD and in patients with asthma receiving Breztri under the approved indication(s) in Korea.
The exploratory objective of this study is to identify patients' baseline characteristics that might be associated with safety and clinical outcomes separately in patients with COPD and in patients with asthma receiving Breztri under the approved indication(s) in Korean patients.
Patients newly initiating treatment with Breztri in accordance with the local prescribing information will be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who have been diagnosed with COPD
Patients who have been diagnosed with asthma
Incidence proportion of Adverse Events (AEs)/Adverse Drug Reactions (ADRs)
All AEs/ADRs will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.
Time frame: 24 weeks
Incidence proportion of Serious AEs (SAEs)/Serious ADRs (SADRs)
SAEs/SADRs will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.
Time frame: 24 weeks
Incidence proportion of Unexpected AEs/Unexpected ADRs
Unexpected AEs/ADRs will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.
Time frame: 24 weeks
Incidence proportion of Unexpected SAEs/Unexpected SADRs
Unexpected SAEs/SADRs, will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.
Time frame: 24 weeks
Describe changes in clinical outcomes from baseline to week 12 and 24 in patients with COPD receiving Breztri under the approved indication(s) in Korea
Change from baseline to week 12 and 24(within a window of ±6 weeks) in predose Forced Expiratory Volume in 1 second (FEV₁) FEV₁ represents the volume of air forcibly exhaled in the first second of a forced expiratory maneuver, measured in milliliters (mL). Improvement indicates enhanced lung function.
Time frame: 12 and 24 weeks
Change from baseline to week 12 and 24 in COPD Assessment Test (CAT) score
Change from baseline to week 12 and 24(within a window of ±6 weeks) in COPD Assessment Test (CAT) score The CAT is an 8-item questionnaire assessing the impact of COPD symptoms on health status. Scores range from 0 (best) to 40 (worst), with lower scores indicating better health status.
Time frame: 12 and 24 weeks
Describe changes in clinical outcomes from baseline to week 12 and 24 in patient with asthma receiving Breztri under the approved indication(s) in Korea
Change from baseline to week 12 and 24(within a window of ±4 weeks) in investigator assessed asthma control Asthma control assessed by the study investigator according to GINA guidelines: "Well controlled", "Partly controlled", and "Uncontrolled".
Time frame: 12 and 24 weeks
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Jul 2027, 10 months after the start.
Of 120 industry-sponsored observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 37. This study's planned 10 months is below that.
Counting every sponsor, half of 586 studies reached it within 26 months; a quarter within 14 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Pulmonary Disease, Chronic Obstructive →