Chronicling the COPD Patient Journey and Change in COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF]

NCT ID: NCT06511193

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 149 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-17
• Study Completion Date: 2026-03-31

Brief Summary

The CHRONICLES study will investigate the change in clinical and patient reported outcomes after six-months of treatment with Budenoside/Glycopyrronium/Formoterol [BGF] in a real-world setting.

Detailed Description

This is a prospective, open label, non-interventional, single network of clinical practice centers study that will be conducted in routine clinical care in the pulmonary/ primary care practitioner (PCP) care setting in Ontario, Canada. Eligible patients will be enrolled into the study only following the treating physician's decision and patient agreement to initiate treatment with BGF. Patients will be observed for up to 6 months post-treatment initiation with BGF.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Budenoside/Glycopyrronium/Formoterol

Patients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria

Budenoside/Glycopyrronium/Formoterol

Intervention Type: DRUG

Patients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria

Interventions

Budenoside/Glycopyrronium/Formoterol

Patients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Physician diagnosis of COPD
• COPD patients in the Best Care Network who have a CAT score >=10
• Age >=35 at time of enrolment
• Minimum 12-month recorded prior medical history for patients
• Physician decision and patient agreement to initiate treatment with Breztri based on routine care (and in accordance with label and reimbursement criteria)
• Ability to read English and to provide consent to inclusion in the study

Exclusion Criteria

• Diagnosis of asthma
• Dementia or other health issues related to memory
• Inability to use inhalers
• COPD due to documented α-1 antitrypsin deficiency
• Previous treatment with triple fixed-dose combination therapy in 12 months prior to screening visit
• Hospitalisation due to COPD exacerbation within the last 30 days prior to enrolment
• Pregnancy or lactation period
• Participation in an ongoing clinical interventional or observational trial for another COPD medication (or completed another trial within last 30 days of initiating BGF)
• Patient self-reporting or a physician record with an active COVID-19 infection at time of enrolment or hospitalized due to COVID-19 infection in the last 60 days
• Previous enrolment in this study

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asthma Research Group Inc.

UNKNOWN

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Windsor, Ontario, Canada

Countries

Canada

Other Identifiers

D5980R00105

Identifier Type: -

Identifier Source: org_study_id