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

April 14, 2026 updated by: Chiesi Farmaceutica Ltda.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
396

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01221-020
        • Recruiting
        • Santa Casa de Misericordia de Sao Paulo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Trimbow
Adult patients with COPD treated with triple combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) as per local clinical practice
Drug: BDP/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)
Other Names:
  • Trimbow

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 months (±2 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of the CAT (COPD assessment test) total score vs baseline at month 3
Time Frame: Baseline and 3 months (±1)
Baseline and 3 months (±1)
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]
Baseline and 6 months (±2)
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]
Baseline and 6 months (±2)
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
Baseline and 6 months (±2)
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]
Baseline and 6 months (±2)
Descriptive statistics
Time Frame: 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
Baseline and 6 months (±2)
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)
6 months (±2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chiesi Farmaceutica Ltda.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: ROBERTO STIRBULOV, PhD, MD, Faculdade de Ciências Médicas da Santa Casa de São Paulo (FCMSCSP)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLI-05993AA1-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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