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.

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.

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

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

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.

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.

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.