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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: budesonide / glycopyrronium / formoterol

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Romania
  • Baia Mare, Romania
    • Research Site
  • Bucharest, Romania
    • Research Site
  • Cluj-Napoca, Romania
    • Research Site
  • Constanța, Romania
    • Research Site
  • Craiova, Romania
    • Research Site
  • Deva, Romania
    • Research Site
  • Dorohoi, Romania
    • Research Site
  • Hunedoara, Romania
    • Research Site
  • Iași, Romania
    • Research Site
  • Luduş, Romania
    • Research Site
  • Medgidia, Romania
    • Research Site
  • Oradea, Romania
    • Research Site
  • Sighișoara, Romania
    • Research Site
  • Suceava, Romania
    • Research Site
  • Timișoara, Romania
    • Research Site
  • Târgu Mureş, Romania
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate to severe COPD who are eligible for BGF MDI therapy may be enrolled by physicians in the specialist care setting.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

COPD patients who initiate treatment with BGF MDI.; 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.

Drug: budesonide / glycopyrronium / formoterol; Trixeo Aerosphere 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension. The COnCORD study is an observational study that will be conducted in a real-life setting in Romania and is not designed to evaluate medicinal products given according to a specific randomised schedule. Treatment with BGF MDI treatment prescribed as per current practice, according to the SmPC and local market reimbursement criteria

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Actual): November 17, 2025
• Study Completion (Actual): November 17, 2025

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Amines; Pregnanes; Steroids; Fused-Ring Compounds; Alcohols; Amino Alcohols; Ethanolamines; Pregnenediones; Pregnenes; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines; Formoterol Fumarate; Budesonide; Glycopyrrolate
• Other Study ID Numbers: D5980R00100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No