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

AstraZeneca2,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide/glycopyrrolate/formoterol fumarateDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Research Site

Mississauga, Canada

NOT_YET_RECRUITING

Research Site

Hamburg, Germany

RECRUITING

Research Site

Athens, Greece

RECRUITING

Outcomes

Primary Outcomes

COPD Assessment Test (CAT)

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

Time frame: 12 weeks

Secondary Outcomes

COPD Assessment Test

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

Time frame: 4 weeks

COPD Assessment Test

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

Time frame: 52 weeks

COPD Assessment Test Responder Rate

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

Time frame: 12 weeks

Treatment Satisfaction Questionnaire for Medication (TSQM)

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

Time frame: 12 weeks and 52 weeks

Annual rate of COPD exacerbations

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)

Time frame: 52 weeks

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

Data from ClinicalTrials.gov

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