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

Official title

A Real-World Study Evaluates the Clinical Characteristics and Effectiveness of COPD Patients Treated With the Triple Combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) in a Single Pressurised Metered Dose Inhaler (Trimbow® pMDI) in Brazil

Overview

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.

Interventions

• Drug BDP/FF/GB (100ug/6ug/12.5ug)
  Fixed 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)

Primary outcome measures

• Assessment of the CAT (COPD assessment test) total score vs baseline at month 6 [Time frame: Baseline and 6 months (±2 months)]

Secondary outcome measures (7)

• Assessment of the CAT (COPD assessment test) total score vs baseline at month 3 [Time frame: Baseline and 3 months (±1)]
• Change of Forced Expiratory Volume in one second assessed via spirometry [Time frame: Baseline and 6 months (±2)]
• Change of Forced Vital Capacity assessed via spirometry [Time frame: Baseline and 6 months (±2)]
• Change of FEV1/FVC ratio assessed via spirometry [Time frame: Baseline and 6 months (±2)]
• Change of Forced Expiratory Flow at 25-75% of forced vital capacity via spirometry [Time frame: Baseline and 6 months (±2)]
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: 6 months (±2)]
• Descriptive statistics [Time frame: Baseline and 6 months (±2)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Brazil · 1 center

• Santa Casa de Misericórdia de São Paulo — São Paulo

Identifiers

NCT: NCT07406048 · CLI-05993AA1-24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗