Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting (CHOROS)

AstraZeneca

Status: Enrolling

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Budesonide/glycopyrrolate/formoterol fumarate

Study type: Observational

Funder types: Industry

Identifiers

NCT06712563

D5980R00084

Details and patient eligibility

About

The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with moderate to severe COPD and initiating BGF treatment according to the local prescribing guidance and as per their treating physician's recommendation
• Enrolled in on-going single-arm studies
• Provided consent for secondary use of data

Exclusion criteria

• Did not provide consent for secondary use of data

Trial design

2,000 participants in 1 patient group

BGF Initiators

Description:

New initiators of BGF without prior BGF exposure

Treatment:

Drug: Budesonide/glycopyrrolate/formoterol fumarate