Real-world effectiveness of the extra-fine BDP/FF/GB triple inhaler in Brazilian COPD patients
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 project will test whether the extra-fine BDP/FF/GB triple inhaler (Trimbow) helps adults in Brazil with severe or very severe COPD feel better and have fewer flare-ups.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 396 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Chiesi Farmaceutici S.p.A. Industry-sponsored |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07406048 on ClinicalTrials.gov |
What this trial studies
This multicenter, observational cohort study in Brazil uses a retrospective‑prospective design to follow about 400 adults with severe or very severe COPD who start the extra‑fine BDP/FF/GB triple inhaler (Trimbow). Baseline clinical data up to 12 months before treatment initiation will be collected from medical records and patients will be followed during routine visits with assessments around 3 ± 1 months and 6 ± 2 months. Treatment is prescribed per standard clinical practice (Trimbow is not provided by the study), and safety and effectiveness outcomes including symptoms, exacerbations, and adverse events will be recorded. Eligible patients must be ≥40 years old, have documented severe or very severe COPD, a CAT score ≥10, and at least one exacerbation in the prior 12 months, with treatment started within three months of enrollment.
Who should consider this trial
Good fit: Adults aged 40 or older in Brazil with documented severe or very severe COPD who have a CAT score ≥10, at least one exacerbation in the past year, and who started Trimbow within three months are the intended candidates.
Not a fit: Patients with mild or moderate COPD, those without recent exacerbations, or those with contraindications to the inhaled components are unlikely to benefit from data generated by this cohort.
Why it matters
Potential benefit: If positive, the results could support that using the extra‑fine BDP/FF/GB triple inhaler improves symptoms and reduces exacerbations in adults with severe COPD, helping clinicians choose therapy.
How similar studies have performed: Randomized trials and some real‑world studies of extra‑fine BDP/FF/GB (Trimbow) and other triple therapies have shown improved symptoms and reduced exacerbations, so this study builds on prior positive evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo, São Paulo
- Santa Casa de Misericórdia de São Paulo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Ismael Pretto Sauter
- Email: Ismael.sauter@chiesi.com
- Phone: +551130952359 / +5511976281117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.