Trial · NCT05862545
Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol)
NCT05862545, Completed, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol). Trials, record NCT05862545. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05862545
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol)
- NCT number
- NCT05862545
- Status
- Completed
- Enrollment
- 250 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- BGF (budesonide/glycopyrrolate/formoterol fumarate)
- First posted
- 2023-05-17
- Last updated
- 2026-03-18
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | COPD Assessment Test (CAT) score | baseline, 12 weeks after treatment start | The change from baseline in COPD Assessment Test (CAT) score after 12 weeks treatment will be analysed using the within person difference between baseline and 12 weeks. Descriptive statistics (mean, median, standard deviation, interquartile range, minimum and maximum) will be provided. The mean change from baseline will be presented along with the 95% CI |
| Secondary | Baseline features | Baseline | To describe the baseline features of patients starting BGF treatment in a real-world setting, in terms of demographics and clinical characteristics, COPD treatment paths and healthcare resource utilization in the previous year. |
| Secondary | Impact of COPD on patients' life based on CAT | baseline, 26 and 52 weeks | To describe the impact of COPD on patients' life, and how it changes over time during the observation period of treatment with BGF, administered as per routine clinical practice. COPD Assessment Test (CAT) questionnaire at baseline and after 26 and 52 weeks after BGF treatment start. In case of patient early withdrawal, CAT questionnaire will also be collected at the end of observation. |
| Secondary | Patients' satisfaction to BGF | baseline, 26 and 52 weeks | 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) at baseline, 26 and 52 weeks from treatment start. In case of patient early withdrawal, TSQM-9 questionnaire will also be collected at the end of observation. |
| Secondary | Patient dyspnoea based on Modified Medical Research Council Dyspnoea Scale (mMRC) | Baseline, 26 and 52 weeks | To describe patient dyspnoea and how it changes over time during the observation period of treatment with BGF, administered as per routine clinical practice. Modified Medical Research Council Dyspnoea Scale (mMRC) questionnaire at baseline, 26 and 52 weeks from treatment start. In case of patient early withdrawal, mMRC questionnaire will also be collected at the end of observation. |
| Secondary | Eosinophil count | baseline, 26 and 52 weeks | To describe the eosinophil count during the observation period of treatment with BGF, administered as per routine clinical practice. Eosinophil count in peripheral blood at baseline visit, and 26- and 52-week visits, which will occur after BGF treatment start, where available. |
| Secondary | Responder Rate based on CAT | 12 weeks | To describe the Responder Rate based on the CAT after 12 weeks of initiating treatment with BGF as per routine clinical practice. Number and rate of responders of the CAT \[MID=2\] after 12 weeks of BGF treatment. |
| Secondary | Overall change in health status based on Patient Global Impression of Severity (PGIS) questionnaire | Baseline, 12, 26 and 52 weeks | To assess patient-reported overall change in health status since the start of study treatment and overall global impression of severity during the observation period of treatment with BGF as per routine clinical practice. Single-item patient severity of COPD symptoms using PGIS at baseline, 12, 26 and 52 weeks after BGF treatment start. In case of patient early withdrawal, PGIS questionnaire will also be collected at the end of observation. |
| Secondary | Exacerbation rate | 52 weeks | To describe the occurrence of moderate - severe COPD exacerbations during the observation period of treatment with BGF, administered as per routine clinical practice. Number of moderate - severe COPD exacerbations, occurred during the BGF observation period and Annualized rate of moderate - severe COPD exacerbations during the BGF treatment observation period |
| Secondary | Lung function | 52 weeks | Describe Lung function parameters as measured at baseline and 52-week visit, available as per routine clinical practice. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
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.
Papers3
The papers the trial lists on ClinicalTrials.gov.
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT05862545
GET https://conductscience.org/api/trials/v1/NCT05862545/registered