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

NCT06511193 | Active Not Recruiting FDA Drug

• 1 other identifier: D5980R00105
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD;; readmissions;; maintenance therapy;; triple therapy;; real-world evidence;; mortality;; cardiopulmonary events,; exacerbations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Demographic and clinical characteristics at baseline

  At baseline

• Change from baseline in CAT score after 24 weeks of treatment

  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

  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

  12 and 24 weeks of treatment initiation

• Percent responders of the CAT [MID=2] after 12 weeks treatment compared to baseline

  12 weeks treatment compared to baseline

Study Arms (1)

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

Interventions

Budenoside/Glycopyrronium/Formoterol DRUG

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

Budenoside/Glycopyrronium/Formoterol

Eligibility Criteria

• Age: 35 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Asthma Research Group Inc.: collaborator
• University Health Network, Toronto: collaborator

Study Sites (1)

Research Site

Windsor, Ontario, N8W 5V7, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 19, 2024
• Study Start: September 17, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

CA (1)