Real-world effectiveness of the extra-fine BDP/FF/GB triple inhaler in Brazilian COPD patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, observational cohort study in Brazil uses a retrospective‑prospective design to follow about 400 adults with severe or very severe COPD who start the extra‑fine BDP/FF/GB triple inhaler (Trimbow). Baseline clinical data up to 12 months before treatment initiation will be collected from medical records and patients will be followed during routine visits with assessments around 3 ± 1 months and 6 ± 2 months. Treatment is prescribed per standard clinical practice (Trimbow is not provided by the study), and safety and effectiveness outcomes including symptoms, exacerbations, and adverse events will be recorded. Eligible patients must be ≥40 years old, have documented severe or very severe COPD, a CAT score ≥10, and at least one exacerbation in the prior 12 months, with treatment started within three months of enrollment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

\- Patient known to be participating in any interventional study during the study period and in the 3 months prior to BDP/FF/GB initiation.

Where it's running

• Santa Casa de Misericórdia de São Paulo
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Ismael Pretto Sauter
• Email: Ismael.sauter@chiesi.com
• Phone: +551130952359 / +5511976281117

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.