Trial · NCT07406048
Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients
NCT07406048, Recruiting, Chiesi Farmaceutica Ltda.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients. Trials, record NCT07406048. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07406048
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients
- NCT number
- NCT07406048
- Status
- Recruiting
- Enrollment
- 396 participants, estimated
- Lead sponsor
- Chiesi Farmaceutica Ltda.
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease)
- Interventions
- BDP/FF/GB (100ug/6ug/12.5ug)
- First posted
- 2026-02-12
- Last updated
- 2026-04-17
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Assessment of the CAT (COPD assessment test) total score vs baseline at month 3 | Baseline and 3 months (±1) | |
| Secondary | 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 \[FEV1 (% pred), mean ± SD\] |
| Secondary | Change of Forced Vital Capacity assessed via spirometry | Baseline and 6 months (±2) | Absolute value of the following parameter: Forced Vital Capacity \[FVC (L), mean ± SD\] |
| Secondary | 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 |
| Secondary | 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 \[FEV25-75 (%), mean ± SD\] |
| Secondary | 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) |
| Secondary | 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 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07406048
GET https://conductscience.org/api/trials/v1/NCT07406048/registered