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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trimbow | Adult patients with COPD treated with triple combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) as per local clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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) |
| 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] |
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Inclusion Criteria:
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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ISMAEL PRETTO SAUTER | Contact | +551130952359 / +5511976281117 | Ismael.sauter@chiesi.com | |
| Medical Information Chiesi | Contact | 0800 110 45 25 | cientifico@chiesi.com |
| Name | Affiliation | Role |
|---|---|---|
| ROBERTO STIRBULOV, PhD, MD | Faculdade de Ciências Médicas da Santa Casa de São Paulo (FCMSCSP) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Casa de Misericórdia de São Paulo | Recruiting | São Paulo | São Paulo | 01221-020 | Brazil |
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|
| 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) |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] |
| 6 months (±2) |
| Descriptive statistics | Patient profile - Descriptive statistics of :
| Baseline and 6 months (±2) |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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