NCT06368427Completed
Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD
A Non-interventional, Multi-centre Study to Investigate the Change in Patient-reported Outcomes in Moderate to Severe COPD Patients Newly Initiated on TRIXEO AEROSPHERE (Budesonide/Glycopyrronium/Formoterol) in Real-life Setting in Romania
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
The purpose of this study is to describe patients' clinical and self-reported outcomes of treatment with budesonide / glycopyrronium / formoterol Metered dose inhaler (BGF MDI) in Romania in real-life setting, up to 6 month of observation period. The study will focus primarily on the change in self-perceived health status in the first 12 weeks (3 months) of treatment with no pre-defined hypothesis.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 10 (actual)
- First submitted
- 11 Apr 2024
- Start date
- 30 Apr 2024
- Primary completion date
- 17 Nov 2025
- Lead sponsor
- AstraZeneca
- Diseases
- COPD
- NCT number
- NCT06368427
What you commit to
- Study type: Observational
- Participants enrolled: 10
- From 30 Apr 2024 to the primary completion date, 17 Nov 2025
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with triple fixed-dose combination in 12 months prior to baseline
- Hospitalization due to COPD exacerbation within the last 30 days prior to index date
- Participation in a non-interventional, observational trial that might, in the investigator's opinion, influence the assessment for the current study, or participation in any interventional clinical trial in the last 30 days prior to baseline.
- Hospitalization for Covid-19 infection in the last 30 days prior to index date
Other illness
- Other uncontrolled disease, that might, in the investigator's opinion, influence the assessment for the current study
Other
- COPD due to known α-1 antitrypsin deficiency
- Pregnancy or lactation period
Who the study is looking for
- Physician-diagnosed COPD
- Initiated treatment with BGF MDI as prescribed according to the summary of product characteristics (SmPC) and local market reimbursement criteria;
- Patients must be able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol
- After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of, and the procedures required for the study and are willing to participate in the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.