Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: budesonide / glycopyrronium / formoterol

• Registration Number: NCT06368427
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

This is a prospective, 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. Furthermore, the patient satisfaction with the medication taken shall be assessed in the real-world setting; an important component that is not usually captured by RCTs. Patients with moderate to severe COPD who are eligible for BGF MDI therapy may be enrolled by physicians in the specialist care setting and the decision to prescribe BGF MDI must be independent of enrollment into the study.

This is a combined primary and secondary data collection study conducted to characterize the population of patients with COPD initiating triple therapy with BGF MDI in real-life setting. Thus, exposure data collected in this study will be primarily on BGF MDI treatment indicated for moderate to severe COPD patients as part of routine medical care. Primary data collection includes PROs; all other data will be documented based on the existing medical records (secondary data collection), either historically or throughout the period of 6-month follow-up, as part of the routine practical care of the patients.

Study Timeline

• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Study Start: 2024-04-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD patients who initiate treatment with BGF MDI.	budesonide / glycopyrronium / formoterol	Patients with COPD, who are eligible for BGF MDI triple therapy. Patients are assigned to a therapeutic strategy within current routine care and not according to a clinical trial protocol. Every medical decision including the course of treatment will reflect exclusively the decision of the treating physician in a routine clinical situation according to the Summary of Product Characteristics of the corresponding medicinal products. There are no dose regimens or diagnostic procedures pre-defined.

Primary Outcome Measures

Name	Time	Method
Change from baseline to 12 weeks (3 months) in the COPD Assessment Test (CAT) score	12 weeks	Compare COPD health status at baseline vs. 12 weeks of initiating treatment with BGF MDI

Secondary Outcome Measures

Name	Time	Method
Change from baseline to 6 months in the CAT score	6 months	Compare COPD health status at baseline vs. 6 months of initiating treatment with BGF MDI
Percent responders of the CAT [MID=2] after 12 weeks of treatment	12 weeks	Describe frequency of Responder Rate based on the CAT after 12 weeks of initiating treatment with BGF MDI
Proportion of days covered (PDC) Time to discontinuation Reasons for treatment discontinuation	6 months	Describe patterns of BGF MDI usage including duration of therapy and discontinuation and reasons for discontinuation
Drivers for initiation or switch to BGF MDI via physician questionnaire	Baseline	To describe the physicians' drivers for initiation or switch to BGF MDI
Treatment Satisfaction Questionnaire for Medication (TSQM) scores after 12 weeks and 6 months of treatment	6 months	Evaluate treatment satisfaction after 12 weeks and 6 months of initiating treatment with BGF MDI

Trial Locations

Locations (1)

Research Site; 🇷🇴 Timisoara, Romania