Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real… (NCT06368427) | Clinical Trial Compass
CompletedNot Applicable
Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD
Romania10 participantsStarted 2024-04-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Change from baseline to 12 weeks (3 months) in the COPD Assessment Test (CAT) score