COPD (Chronic Obstructive Pulmonary Disease)RETRIBUTENCT07406048
Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients
An observational study of COPD (Chronic Obstructive Pulmonary Disease), run by Chiesi Farmaceutica Ltda. at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- BDP/FF/GB (100ug/6ug/12.5ug)
- How many people
- 396 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patient known to be participating in any interventional study during the study period and in the 3 months prior to BDP/FF/GB initiation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, 01221-020
José Eduardo Cançado, PhD, educancado@uol.com.br
About this study
Official 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
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.
- Being tested
- BDP/FF/GB (100ug/6ug/12.5ug)
- Keywords
- COPD, Real-world evidence, extra-fine particule, Trimbow, Fixed Triple Therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDP/FF/GB (100ug/6ug/12.5ug)Drug
Also called Trimbow
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)
| Study group | Role | What they receive |
|---|---|---|
| Trimbow | Adult patients with COPD treated with triple combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) as per local clinical practice Receives: Drug: BDP/FF/GB (100ug/6ug/12.5ug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months (±2 months)
Secondary outcomes (7)
Assessment of the CAT (COPD assessment test) total score vs baseline at month 3
Measured: 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]
Measured: 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]
Measured: 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
Measured: 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]
Measured: Baseline and 6 months (±2)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- 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)
Measured: 6 months (±2)
Descriptive statistics
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
Measured: Baseline and 6 months (±2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutica Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ROBERTO STIRBULOV, PhD, MD, Study chair, Faculdade de Ciências Médicas da Santa Casa de São Paulo (FCMSCSP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406048
- Sponsor's protocol ID
- CLI-05993AA1-24
- Acronym
- RETRIBUTE
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07406048
- Acronym / sponsor ID
- RETRIBUTE / CLI-05993AA1-24
- Keywords
- COPD, Real-world evidence, extra-fine particule, Trimbow, Fixed Triple Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- Chiesi Farmaceutica Ltda.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trimbow | – | Drug: BDP/FF/GB (100ug/6ug/12.5ug)Adult patients with COPD treated with triple combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) as per local clinical practice |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- Patient known to be participating in any interventional study during the study period and in the 3 months prior to BDP/FF/GB initiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BDP/FF/GB (100ug/6ug/12.5ug)Also: TrimbowFixed 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) | Drug | Trimbow |
Primary outcome
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.
7 secondary outcomes
Assessment of the CAT (COPD assessment test) total score vs baseline at month 3
Time frame: Baseline and 3 months (±1)
Change of Forced Expiratory Volume in one second assessed via spirometry
Time frame: Baseline and 6 months (±2)
Change of Forced Vital Capacity assessed via spirometry
Time frame: Baseline and 6 months (±2)
Change of FEV1/FVC ratio assessed via spirometry
Time frame: 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)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 6 months (±2)
Descriptive statistics
Time frame: Baseline and 6 months (±2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ROBERTO STIRBULOV, PhD, MD study chair
Faculdade de Ciências Médicas da Santa Casa de São Paulo (FCMSCSP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD (Chronic Obstructive Pulmonary Disease), run by Chiesi Farmaceutica Ltda. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ISMAEL PRETTO SAUTER (+551130952359 / +5511976281117, Ismael.sauter@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the CAT (COPD assessment test) total score vs baseline at month 6 (time frame: Baseline and 6 months (±2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.