Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06712563

Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting

The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Mississauga, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with moderate to severe COPD and initiating BGF treatment according to the local prescribing guidance and as per their treating physician's recommendation
  • Enrolled in on-going single-arm studies
  • Provided consent for secondary use of data

Exclusion criteria

  • Did not provide consent for secondary use of data

Treatment and study plan

Budesonide/glycopyrrolate/formoterol fumarate

Drug

Budesonide/glycopyrrolate/formoterol fumarate (BGF) is a triple fixed-dose combination therapy for adults with moderate to severe COPD who are not adequately treated by a combination of inhaled corticosteroids and long-acting beta-agonist (LABA), or LABA and long-acting muscarinic-antagonist

Other names: BGF, Breztri

Primary outcomes

  1. COPD Assessment Test (CAT)

    Time frame: 12 weeks

    Compare self-reported COPD health status measured by COPD Assessment Test (CAT) at 12 weeks/3 months as compared to baseline in patients initiating treatment with BGF

Secondary outcomes

  1. COPD Assessment Test

    Time frame: 4 weeks

    To compare self-reported COPD health status measured by CAT at 4 weeks/1 month as compared to baseline in patients initiating treatment with BGF

  2. COPD Assessment Test

    Time frame: 52 weeks

    To compare self-reported COPD health status measured by CAT at 52 weeks/12 months as compared to baseline in patients initiating treatment with BGF

  3. COPD Assessment Test Responder Rate

    Time frame: 12 weeks

    To describe the frequency and proportion of responders of the CAT questionnaire after 12 weeks/3 months of initiating treatment with BGF

  4. Treatment Satisfaction Questionnaire for Medication (TSQM)

    Time frame: 12 weeks and 52 weeks

    To evaluate treatment satisfaction using Treatment Satisfaction Questionnaire for Medication (TSQM) after 12 weeks/3months and 52 weeks/12 months of initiating treatment with BGF

  5. Annual rate of COPD exacerbations

    Time frame: 52 weeks

    To compare the annual rates of moderate and severe exacerbations for the follow-up period (up to 52 weeks/12 months) versus the baseline period (12 months prior to initiating BGF)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study title

Pooled Analysis of Multi-country, Open-label Single-arm, Non-interventional, Multi-center, Cohort Studies of Real-world Outcomes in New Users of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting

Acronym: CHOROS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.