BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA (Breztri rPMS)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This is an open-label, 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 assess safety profile for patients receiving Breztri under the approved indication(s) in Korea.
The secondary objective of this study is to assess effectiveness for patients 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 effectiveness for patients receiving Breztri under the approved indication(s) in Korean patients.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: AstraZeneca Clinical Study Information Center
- Numero di telefono: 1-877-240-9479
- Email: information.center@astrazeneca.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patients who have been diagnosed with COPD.
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence proportion of Adverse Events (AEs)/Adverse Drug Reactions (ADRs)
Lasso di tempo: 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.
|
24 weeks
|
|
Incidence proportion of Serious AEs (SAEs)/Serious ADRs (SADRs)
Lasso di tempo: 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.
|
24 weeks
|
|
Incidence proportion of Unexpected AEs/Unexpected ADRs
Lasso di tempo: 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.
|
24 weeks
|
|
Incidence proportion of Unexpected SAEs/Unexpected SADRs
Lasso di tempo: 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.
|
24 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from baseline to week 12 and 24 in pre-dose Forced Expiratory Volume in 1 second (FEV₁)
Lasso di tempo: 12 or 24 weeks
|
Effectiveness analyses will be performed for effectiveness analysis population, defined as patients among the safety population who (i) have completed 12 or 24 weeks of treatment with Breztri, and (ii) have available FEV₁ data both at baseline (within 30 days prior to the first dose of Breztri) and at a visit occurring within 6 weeks prior to or subsequent to the 12- or 24-week treatment timepoint.
If multiple measurements are available within this time window, the value closest to the 12- and 24-week target will be used.
|
12 or 24 weeks
|
|
Change from baseline to week 12 and 24 in COPD Assessment Test (CAT) score
Lasso di tempo: 12 or 24 weeks
|
Effectiveness analyses will be performed for effectiveness analysis population, defined as patients among the safety population who (i) have completed 12 or 24 weeks of treatment with Breztri, and (ii) have available CAT score data both at baseline (within 30 days prior to the first dose of Breztri) and at a visit occurring within 6 weeks prior to or subsequent to the 12- or 24-week treatment timepoint.
If multiple measurements are available within this time window, the value closest to the 12- and 24-week target will be used.
|
12 or 24 weeks
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- D5980R00025
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Periodo di condivisione IPD
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.
Criteri di accesso alla condivisione IPD
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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