NCT07406048 Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients
| NCT ID | NCT07406048 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chiesi Farmaceutica Ltda. |
| Condition | COPD (Chronic Obstructive Pulmonary Disease) |
| Study Type | OBSERVATIONAL |
| Enrollment | 396 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 396 participants in total. It began in 2026-04-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
ROBERTO STIRBULOV, PhD, MD
STUDY CHAIR
Faculdade de Ciências Médicas da Santa Casa de São Paulo (FCMSCSP)
Frequently Asked Questions
Who can join the NCT07406048 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying COPD (Chronic Obstructive Pulmonary Disease). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07406048 currently recruiting?
Yes, NCT07406048 is actively recruiting participants. Contact the research team at Ismael.sauter@chiesi.com for enrollment information.
Where is the NCT07406048 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07406048 clinical trial?
NCT07406048 is sponsored by Chiesi Farmaceutica Ltda.. The principal investigator is ROBERTO STIRBULOV, PhD, MD at Faculdade de Ciências Médicas da Santa Casa de São Paulo (FCMSCSP). The trial plans to enroll 396 participants.
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