Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
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.
Interventions
DRUGBudesonide/glycopyrrolate/formoterol fumarate
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
Sponsors
AstraZeneca
IQVIA Pty Ltd
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COPD Assessment Test (CAT) | 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
| Measure | Time frame | Description |
|---|---|---|
| COPD Assessment Test | 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 |
| COPD Assessment Test Responder Rate | 12 weeks | To describe the frequency and proportion of responders of the CAT questionnaire after 12 weeks/3 months of initiating treatment with BGF |
| Treatment Satisfaction Questionnaire for Medication (TSQM) | 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 |
| Annual rate of COPD exacerbations | 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) |
Countries
Canada, Germany, Greece, Italy, Japan, Romania, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORMichael F Pollack, MS
AstraZeneca
Outcome results
None listed