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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Drug: BDP/FF/GB (100ug/6ug/12.5ug)

• Study Type: Observational
• Enrollment (Estimated): 396

Contacts and Locations

• Study Contact: Name: ISMAEL PRETTO SAUTER; Phone Number: +551130952359 / +5511976281117; Email: Ismael.sauter@chiesi.com
• Study Contact Backup: Name: Medical Information Chiesi; Phone Number: 0800 110 45 25; Email: cientifico@chiesi.com

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01221-020
      • Recruiting
      • Santa Casa de Misericordia de Sao Paulo
      • Contact: José Eduardo Cançado, PhD; Email: educancado@uol.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trimbow; Adult patients with COPD treated with triple combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) as per local clinical practice	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); Other Names: Trimbow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 6 months (±2 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the CAT (COPD assessment test) total score vs baseline at month 3		Baseline and 3 months (±1)
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]	Baseline and 6 months (±2)
Change of Forced Vital Capacity assessed via spirometry	Absolute value of the following parameter: Forced Vital Capacity [FVC (L), mean ± SD]	Baseline and 6 months (±2)
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	Baseline and 6 months (±2)
Change of Forced Expiratory Flow at 25-75% of forced vital capacity via spirometry	Absolute value of the following parameter: Forced Expiratory Flow at 25-75% of forced vital capacity [FEV25-75 (%), mean ± SD]	Baseline and 6 months (±2)
Descriptive statistics	Patient profile - Descriptive statistics of : Demographic Data: Age; Sex; and State/region of residence.; Clinical characteristicsSmoking historyCOPD characteristicsRelevant medical historyCOPD treatmentConcomitant medicationsVital signs	Baseline and 6 months (±2)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Overall summary of adverse drug reactions (ADRs) will be presented the number of subjects and percentage of subjects with any ADRs, including suspected ADRs and serious ADRs (e.g., nasopharyngitis, pneumonia, hypertension, headache, ischaemic heart disease, angina pectoris, myocardial infarction, myocardial ischaemia, coronary artery disease, respiratory tract infection viral, oral candidosis, muscle spasms, dry mouth, among others); Overall summary of serious adverse events (SAE) will be presented the number of subjects and percentage of subjects with any SAE (e.g., nasopharyngitis, pneumonia, hypertension, headache, ischaemic heart disease, angina pectoris, myocardial infarction, myocardial ischaemia, coronary artery disease, respiratory tract infection viral, oral candidosis, muscle spasms, dry mouth, among others)	6 months (±2)

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutica Ltda.
• Investigators: Study Chair: ROBERTO STIRBULOV, PhD, MD, Faculdade de Ciências Médicas da Santa Casa de São Paulo (FCMSCSP)

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: COPD; Real-world evidence; Trimbow; extra-fine particule; Fixed Triple Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CLI-05993AA1-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No