NCT07406048Recruiting
Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose 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
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 396 (estimated)
- First submitted
- 13 Jan 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Chiesi Farmaceutica Ltda.
- Diseases
- COPD
- NCT number
- NCT07406048
What you commit to
- Study type: Observational
- Planned participants: 396
- From 1 Apr 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- Patient known to be participating in any interventional study during the study period and in the 3 months prior to BDP/FF/GB initiation.
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Santa Casa de Misericordia de Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.