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

NCT07406048 | Recruiting

• 1 other identifier: CLI-05993AA1-24
• Study Type: observational
• Target: 396
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

COPD; Real-world evidence; extra-fine particule; Trimbow; Fixed Triple Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  Baseline and 6 months (±2)

• Change of Forced Vital Capacity assessed via spirometry

  Baseline and 6 months (±2)

• Change of FEV1/FVC ratio assessed via spirometry

  Baseline and 6 months (±2)

• Change of Forced Expiratory Flow at 25-75% of forced vital capacity via spirometry

  Baseline and 6 months (±2)

Study Arms (1)

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)

Interventions

BDP/FF/GB (100ug/6ug/12.5ug) DRUG

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)

Also known as: Trimbow

Trimbow

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- Patient known to be participating in any interventional study during the study period and in the 3 months prior to BDP/FF/GB initiation.

Sponsors & Collaborators

• Chiesi Farmaceutica Ltda.: lead

Study Sites (1)

Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, 01221-020, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ROBERTO STIRBULOV, PhD, MD

  Faculdade de Ciências Médicas da Santa Casa de São Paulo (FCMSCSP)

  STUDY CHAIR

Central Study Contacts

ISMAEL PRETTO SAUTER

CONTACT

+551130952359 / +5511976281117; Ismael.sauter@chiesi.com

Medical Information Chiesi

CONTACT

0800 110 45 25; cientifico@chiesi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)