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.
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.
None
Brazilian patients aged ≥ 40 years old, diagnosed with severe and very severe COPD and with a CAT total score ≥ 10 at baseline, under treatment or who will initiate BDP/FF/GB treatment without previous use of single- inhaler triple therapy. Inclusion and exclusion criteria are listed above.
Cohort
Other
BDP/FF/GB (100ug/6ug/12.5ug)
DrugFixed combination of Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA) / long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate (BDP), Formoterol fumarate (FF) and Glycopyrronium bromide(GB)
Assessment of the CAT (COPD assessment test) total score vs baseline at month 6
The test has a score of 0 (minimum) - 40 (maximum); a lower score means a better outcome, and a higher score means a worse outcome.
Assessment of the CAT (COPD assessment test) total score vs baseline at month 3
Change of Forced Expiratory Volume in one second assessed via spirometry
Absolute value and percent of predicted normal of the following parameter: Forced Expiratory Volume in one second \[FEV1 (L), mean ± SD (standard deviation)\]; Percent predict FEV1 \[FEV1 (% pred), mean ± SD\]
Change of Forced Vital Capacity assessed via spirometry
Absolute value of the following parameter: Forced Vital Capacity \[FVC (L), mean ± SD\]
Change of FEV1/FVC ratio assessed via spirometry
Absolute value of the following parameter: Forced Expiratory Volume in one second / Forced Vital Capacity ratio: mean ± SD
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