Status:
ACTIVE_NOT_RECRUITING
Chronicling the COPD Patient Journey and Change in COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF]
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Asthma Research Group Inc.
University Health Network, Toronto
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
35-130 years
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 (PC...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 17 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT06511193
Start Date
September 17 2024
End Date
March 31 2026
Last Update
December 2 2025
Active Locations (1)
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1
Research Site
Windsor, Ontario, Canada, N8W 5V7