Real-world use of a triple-drug inhaler in people with COPD in Brazil
Follows adults with severe or very severe COPD using a triple inhaler.
Plain-language title generated from the registry record
Registry title: Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients
Key facts
- Where
- São Paulo, BrazilSee the site
Where in Brazil
- Santa Casa de Misericordia de Sao PauloSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chiesi Farmaceutica Ltda.
- Trial code
- NCT07406048
- Record updated
- 17 April 2026
- Original description
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.Read full original descriptionShow less
A Real-World Study Evaluates the Clinical Characteristics and Effectiveness of COPD Patients Treated With the Triple Combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) in a Single Pressurised Metered Dose Inhaler (Trimbow® pMDI) in Brazil
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.
Inclusion: Male and Female patients ≥ 40 years old at the time of BDP/FF/GB initiation; Patients with documented diagnosis of severe or very severe COPD prior to BDP/FF/GB initiation; Patients with CAT total score ≥ 10 at baseline (at the time of BDP/FF/GB initiation or within the 12 months before treatment initiation*) *If no CAT total score is available on BDP/FF/GB initiation date); Patients with at least ≥ 1 COPD exacerbation within the previous 12 months before enrollment; Patients who started treatment with BDP/FF/GB within 3-months before signing the Informed Consent Form (ICF), or on the date of the ICF signature according to Trimbow® Summary of Product Characteristics (SmPC); Patients who are willing and able to give their written consent to participate in the study.
Exclusion: Patient known to be participating in any interventional study during the study period and in the 3 months prior to BDP/FF/GB initiation.