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

NCT06368427 | Completed

• 1 other identifier: D5980R00100
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 16

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline to 6 months in the CAT score

  6 months

• Treatment Satisfaction Questionnaire for Medication (TSQM) scores after 12 weeks and 6 months of treatment

  6 months

• Percent responders of the CAT [MID=2] after 12 weeks of treatment

  12 weeks

• Proportion of days covered (PDC) Time to discontinuation Reasons for treatment discontinuation

  6 months

• Drivers for initiation or switch to BGF MDI via physician questionnaire

  Baseline

Study Arms (1)

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

Interventions

budesonide / glycopyrronium / formoterol DRUG

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

COPD patients who initiate treatment with BGF MDI.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (16)

Research Site

Baia Mare, Romania

Location

Research Site

Bucharest, Romania

Location

Research Site

Cluj-Napoca, Romania

Location

Research Site

Constanța, Romania

Location

Research Site

Craiova, Romania

Location

Research Site

Deva, Romania

Location

Research Site

Dorohoi, Romania

Location

Research Site

Hunedoara, Romania

Location

Research Site

Iași, Romania

Location

Research Site

Luduş, Romania

Location

Research Site

Medgidia, Romania

Location

Research Site

Oradea, Romania

Location

Research Site

Sighișoara, Romania

Location

Research Site

Suceava, Romania

Location

Research Site

Târgu Mureş, Romania

Location

Research Site

Timișoara, Romania

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide; Glycopyrrolate; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: April 30, 2024
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

RO (16)