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

N/AActive Not RecruitingNCT06511193

AstraZeneca152 enrolled

Overview

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.

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

152

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Budenoside/Glycopyrronium/FormoterolDRUG

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

Eligibility

Sex: ALLMin age: 35 YearsMax age: 130 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Windsor, Ontario, Canada

Outcomes

Primary Outcomes

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

Time frame: 12 weeks after treatment initiation

Secondary Outcomes

Demographic and clinical characteristics at baseline

To describe the demographic and clinical characteristics of patients in the study

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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