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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— COnCORD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368427
• Other study ID #: D5980R00100
• Status: Recruiting
• Start date: April 30, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 a-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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Romania	Research Site	Baia Mare
Romania	Research Site	Bucuresti
Romania	Research Site	Bucuresti
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Constanta
Romania	Research Site	Craiova
Romania	Research Site	Deva
Romania	Research Site	Dorohoi
Romania	Research Site	Hunedoara
Romania	Research Site	Iasi
Romania	Research Site	Suceava
Romania	Research Site	Targu Mures
Romania	Research Site	Timisoara

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Drivers for initiation or switch to BGF MDI via physician questionnaire	To describe the physicians' drivers for initiation or switch to BGF MDI	Baseline