NCT06511193

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

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)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 152 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 35 Years – 130 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	Budenoside/Glycopyrronium/Formoterol	Patients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria

Timeline

• Start date: 2024-09-17
• Primary completion: 2026-05-20
• Completion: 2026-05-20
• First posted: 2024-07-19
• Last updated: 2026-02-04

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study