BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA (Breztri rPMS)
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: AstraZeneca Clinical Study Information Center
- Puhelinnumero: 1-877-240-9479
- Sähköposti: information.center@astrazeneca.com
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Incidence proportion of Adverse Events (AEs)/Adverse Drug Reactions (ADRs)
Aikaikkuna: 24 weeks
|
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)
Aikaikkuna: 24 weeks
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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
Aikaikkuna: 24 weeks
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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
Aikaikkuna: 24 weeks
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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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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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
Aikaikkuna: 12 and 24 weeks
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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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Patologiset prosessit
- Krooninen sairaus
- Sairauden ominaisuudet
- Immuunijärjestelmän sairaudet
- Hengityselinten sairaudet
- Keuhkosairaudet
- Keuhkoputken sairaudet
- Keuhkosairaudet, obstruktiiviset
- Hengitysteiden yliherkkyys
- Yliherkkyys, välitön
- Yliherkkyys
- Patologiset tilat, merkit ja oireet
- Keuhkosairaus, krooninen obstruktiivinen
- Astma
Muut tutkimustunnusnumerot
- D5980R00025
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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-jaon aikakehys
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-jaon käyttöoikeuskriteerit
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.
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