Actively Recruiting
Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients
Led by Chiesi Farmaceutica Ltda. · Updated on 2026-04-17
396
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This multicenter, retrospective-prospective, cohort study aims to evaluate the effectiveness and safety of Extra-fine Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (EF-BDP/FF/GB) therapy in adults with severe or very severe COPD in Brazil. Around 400 patients will be enrolled across approximately 15 sites. Eligible patients must have started treatment on the day of enrollment or up to three months before enrollment. Data will be collected both retrospectively and prospectively, with baseline information covering up to 12 months before treatment initiation. All assessments will occur during routine medical visits, with follow-up expected at approximately 3 ± 1 month and 6 months ± 2 months. The medication Trimbow® will not be provided as part of the study and must be prescribed and used according to the institution's standard clinical practice, regardless of participation in the study.
CONDITIONS
Official Title
Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 40 years or older at the time of starting BDP/FF/GB treatment
- Documented diagnosis of severe or very severe COPD before starting BDP/FF/GB
- COPD Assessment Test (CAT) total score of 10 or higher at baseline or within 12 months before treatment
- At least one COPD exacerbation in the 12 months before enrollment
- Started treatment with BDP/FF/GB within 3 months before or on the date of signing informed consent
- Willing and able to provide written consent to participate in the study
You will not qualify if you...
- Participation in any interventional study during this study period or in the 3 months before starting BDP/FF/GB
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, Brazil, 01221-020
Actively Recruiting
Research Team
I
ISMAEL PRETTO SAUTER
CONTACT
M
Medical Information Chiesi
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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