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

Chronicling the COPD Patient Journey and Change in Impact of a Single Inhaler Combination Therapy on COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF](CHRONICLES COPD)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Budenoside/Glycopyrronium/Formoterol

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.

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Windsor, Ontario, Canada, N8W 5V7
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with moderate to severe COPD who are eligible for BGF therapy may be enrolled by physicians in primary care setting. The decision to start treatment with BGF must be made by the treating physician according to the subjects' medical need and a positive benefit/risk balance. The decision to prescribe BGF must be independent of enrolment into the study, is determined by the treating physician and should be taken according to the standard of current best medical practice and national guidelines.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Budenoside/Glycopyrronium/Formoterol; Patients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria	Drug: Budenoside/Glycopyrronium/Formoterol; Patients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in the COPD Assessment Test (CAT) score	To estimate the change in COPD health status in patients initiating BGF after 12 weeks	12 weeks after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic and clinical characteristics at baseline	To describe the demographic and clinical characteristics of patients in the study	At baseline
Change from baseline in CAT score after 24 weeks of treatment	To estimate the change in COPD health status after 24 weeks from treatment initiation	24 weeks from treatment initiation
Change in patient quality of life as measured by EQ-5D-5L at 12 and 24 weeks post-treatment initiation	To estimate the change in patient quality of life after 12 and 24 weeks of treatment initiation	12 and 24 weeks after treatment initiation
Change in measures of sleep quality using CASIS (COPD and Asthma Sleep Impact Scale) at weeks 12 and 24	To estimate change in sleep quality following introduction of BGF	12 and 24 weeks of treatment initiation
Percent responders of the CAT [MID=2] after 12 weeks treatment compared to baseline	To describe the Responder Rate based on the CAT after 12 weeks of initiating treatment with BGF	12 weeks treatment compared to baseline
The annualized rate of moderate and severe exacerbations that occurred within the previous year is collected at the baseline visit and the number of moderate and severe exacerbations occurring during the study is collected at the final visit	To describe and compare the rate of moderate and severe exacerbations	Baseline (12 months prior to initiating BGF) and during the follow-up period (up to 6 months))

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: University Health Network, Toronto; Asthma Research Group Inc.
• Investigators: Principal Investigator: Christopher James Licskai, MD, Best Care Network (Asthma Research Group Windsor Essex County INC) 1641 Provincial Road Windsor, Ontario, N8W 5V7 Canada

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: exacerbations; COPD;; readmissions;; maintenance therapy;; triple therapy;; real-world evidence;; mortality;; cardiopulmonary events,
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Adjuvants, Anesthesia; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Formoterol Fumarate; Glycopyrrolate
• Other Study ID Numbers: D5980R00105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.

IPD Sharing Access Criteria

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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No