COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
COPD, Real-world evidence, extra-fine particule, Trimbow, Fixed Triple Therapy
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.
Interventions
DRUGBDP/FF/GB (100ug/6ug/12.5ug)
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)
Sponsors
Chiesi Farmaceutica Ltda.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the CAT (COPD assessment test) total score vs baseline at month 6 | Baseline and 6 months (±2 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 \[FEV1 (% pred), mean ± SD\] |
| Change of Forced Vital Capacity assessed via spirometry | Baseline and 6 months (±2) | Absolute value of the following parameter: Forced Vital Capacity \[FVC (L), mean ± SD\] |
| Change of FEV1/FVC ratio assessed via spirometry | Baseline and 6 months (±2) | Absolute value of the following parameter: Forced Expiratory Volume in one second / Forced Vital Capacity ratio: mean ± SD |
| Change of Forced Expiratory Flow at 25-75% of forced vital capacity via spirometry | Baseline and 6 months (±2) | Absolute value of the following parameter: Forced Expiratory Flow at 25-75% of forced vital capacity \[FEV25-75 (%), mean ± SD\] |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 6 months (±2) | * Overall summary of adverse drug reactions (ADRs) will be presented the number of subjects and percentage of subjects with any ADRs, including suspected ADRs and serious ADRs (e.g., nasopharyngitis, pneumonia, hypertension, headache, ischaemic heart disease, angina pectoris, myocardial infarction, myocardial ischaemia, coronary artery disease, respiratory tract infection viral, oral candidosis, muscle spasms, dry mouth, among others) * Overall summary of serious adverse events (SAE) will be presented the number of subjects and percentage of subjects with any SAE (e.g., nasopharyngitis, pneumonia, hypertension, headache, ischaemic heart disease, angina pectoris, myocardial infarction, myocardial ischaemia, coronary artery disease, respiratory tract infection viral, oral candidosis, muscle spasms, dry mouth, among others) |
| Descriptive statistics | Baseline and 6 months (±2) | Patient profile - Descriptive statistics of : 1. Demographic Data: Age; Sex; and State/region of residence. 2. Clinical characteristics * Smoking history * COPD characteristics * Relevant medical history * COPD treatment * Concomitant medications * Vital signs |
Countries
Brazil
Contacts
CONTACTISMAEL PRETTO SAUTER
CONTACTMedical Information Chiesi
STUDY_CHAIRROBERTO STIRBULOV, PhD, MD
Faculdade de Ciências Médicas da Santa Casa de São Paulo (FCMSCSP)
Outcome results
None listed