NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA

Not Yet RecruitingN/A

Sponsor: AstraZeneca

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Patients who have been diagnosed with COPD.
2. Patients who have newly initiated treatment with Breztri according to the approved label in Korea
3. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria:

1. Other off-label indications outside of the locally approved prescribing information
2. Pregnant and/or breast feeding
3. Current participation in any interventional trial