Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients
Recruiting · NCT07406048 · Observational (researchers observe without assigning treatment) · Lead sponsor: Chiesi Farmaceutica Ltda.
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
1 location listed.
- Santa Casa de Misericórdia de São Paulo - São Paulo, São Paulo, Brazil