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

ConditionPulmonary Disease, Chronic Obstructive
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Did not provide consent for secondary use of data

Trial population

Patients with COPD who are new initiators of BGF enrolled in several planned and on-going prospective, non-interventional single-arm studies. Eligible patients for the individual studies are those with moderate to severe COPD and initiating BGF treatment according to the local prescribing guidance and as per their treating physician's recommendation. Only patients that have signed an informed consent form (ICF) allowing the secondary use of their data will be eligible for the CHOROS pooled analysis.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: BGF Initiators1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

IQVIA Pty Ltd

Collaborator

Source ClinicalTrials.gov
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