BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA (Breztri rPMS)
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: AstraZeneca Clinical Study Information Center
- Telefoonnummer: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Patients who have been diagnosed with COPD or asthma.
- Patients who have newly initiated treatment with Breztri according to the approved label in Korea
- Provision of signed and dated written informed consent by the patient or legally acceptable representative
Exclusion Criteria:
- Other off-label indications outside of the locally approved prescribing information
- Pregnant and/or breast feeding
- Current participation in any interventional trial
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Chronic obstructive pulmonary disease
Patients who have been diagnosed with COPD
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Asthma
Patients who have been diagnosed with asthma
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence proportion of Adverse Events (AEs)/Adverse Drug Reactions (ADRs)
Tijdsspanne: 24 weeks
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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.
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24 weeks
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Incidence proportion of Serious AEs (SAEs)/Serious ADRs (SADRs)
Tijdsspanne: 24 weeks
|
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.
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24 weeks
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Incidence proportion of Unexpected AEs/Unexpected ADRs
Tijdsspanne: 24 weeks
|
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.
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24 weeks
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Incidence proportion of Unexpected SAEs/Unexpected SADRs
Tijdsspanne: 24 weeks
|
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.
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24 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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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
Tijdsspanne: 12 and 24 weeks
|
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.
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12 and 24 weeks
|
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Change from baseline to week 12 and 24 in COPD Assessment Test (CAT) score
Tijdsspanne: 12 and 24 weeks
|
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.
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12 and 24 weeks
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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
Tijdsspanne: 12 and 24 weeks
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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". |
12 and 24 weeks
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Chronische ziekte
- Ziekte attributen
- Ziekten van het immuunsysteem
- Ziekten van de luchtwegen
- Longziekten
- Bronchiale ziekten
- Longziekten, obstructief
- Ademhalingsovergevoeligheid
- Overgevoeligheid, Onmiddellijk
- Overgevoeligheid
- Pathologische aandoeningen, tekenen en symptomen
- Longziekte, chronisch obstructief
- Astma
Andere studie-ID-nummers
- D5980R00025
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
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.
IPD-toegangscriteria voor delen
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.
Informatie over medicijnen en apparaten, studiedocumenten
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