Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorChiesi Farmaceutica Ltda.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • BDP/FF/GB (100ug/6ug/12.5ug)

Treatment groups

396 Participants
are divided into 1 treatment group

Sponsors and collaborators