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Evaluating patient outcomes in COPD patients using TRIXEO AEROSPHERE

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

Observational AstraZeneca · NCT06368427

This study is trying to see how well TRIXEO AEROSPHERE helps people with moderate to severe COPD feel better over six months in Romania.

Quick facts

Study typeObservational
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Locations18 sites (Baia Mare and 17 other locations)
Trial IDNCT06368427 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the clinical and self-reported outcomes of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) who are newly initiated on TRIXEO AEROSPHERE (budesonide / glycopyrronium / formoterol) in Romania. The study will follow patients for up to six months, focusing on changes in their self-perceived health status, particularly during the first 12 weeks of treatment. Data will be collected through patient-reported outcomes and existing medical records, allowing for a comprehensive understanding of patient satisfaction and treatment effectiveness in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with moderate to severe COPD who are starting treatment with BGF MDI.

Not a fit: Patients with COPD due to known α-1 antitrypsin deficiency or those who have received triple therapy in the past year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and patient satisfaction of TRIXEO AEROSPHERE for managing COPD.

How similar studies have performed: While this approach is observational and focuses on real-world outcomes, similar studies have shown success in capturing patient-reported outcomes in chronic disease management.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* COPD due to known α-1 antitrypsin deficiency
* 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
* Pregnancy or lactation period
* Other uncontrolled disease, that might, in the investigator's opinion, influence the assessment for the current study
* 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

Where this trial is running

Baia Mare and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Obstructive Pulmonary Disease
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.