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

AstraZeneca

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: budesonide / glycopyrronium / formoterol

Study type: Observational

Funder types: Industry

Identifiers

NCT06368427

D5980R00100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

COPD patients who initiate treatment with BGF MDI.

Description:

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.

Treatment:

Drug: budesonide / glycopyrronium / formoterol