Condition: COPD (Chronic Obstructive Pulmonary Disease) · Sponsor: Chiesi Farmaceutica Ltda.
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.
This description comes directly from the study's public registry record.
ISMAEL PRETTO SAUTER · +551130952359 / +5511976281117 · Ismael.sauter@chiesi.com
Medical Information Chiesi · 0800 110 45 25 · cientifico@chiesi.com
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| Santa Casa de Misericórdia de São Paulo | São Paulo, São Paulo, Brazil | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07406048