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NCT Number: NCT07406048

Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients

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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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Santa Casa de Misericórdia de São Paulo

São Paulo, 01221-020, Brazil

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other names: Trimbow

Primary outcomes

  1. Assessment of the CAT (COPD assessment test) total score vs baseline at month 6

    Time frame: 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 outcomes

  1. Assessment of the CAT (COPD assessment test) total score vs baseline at month 3

    Time frame: Baseline and 3 months (±1)

  2. Change of Forced Expiratory Volume in one second assessed via spirometry

    Time frame: 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]

  3. Change of Forced Vital Capacity assessed via spirometry

    Time frame: Baseline and 6 months (±2)

    Absolute value of the following parameter: Forced Vital Capacity [FVC (L), mean ± SD]

  4. Change of FEV1/FVC ratio assessed via spirometry

    Time frame: Baseline and 6 months (±2)

    Absolute value of the following parameter: Forced Expiratory Volume in one second / Forced Vital Capacity ratio: mean ± SD

  5. Change of Forced Expiratory Flow at 25-75% of forced vital capacity via spirometry

    Time frame: 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]

  6. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: 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)

  7. Descriptive statistics

    Time frame: Baseline and 6 months (±2)

    Patient profile - Descriptive statistics of :

    • Demographic Data: Age; Sex; and State/region of residence.
    • Clinical characteristics
    • Smoking history
    • COPD characteristics
    • Relevant medical history
    • COPD treatment
    • Concomitant medications
    • Vital signs

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutica Ltda.

Industry

Registry information

Official study title

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

Acronym: RETRIBUTE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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