Clinical trial NCT06368427: Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to 12 weeks (3 months) in the COPD Assessment Test (CAT) score
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline to 6 months in the CAT score
timeFrame: 6 months
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) scores after 12 weeks and 6 months of treatment
timeFrame: 6 months
measure: Percent responders of the CAT [MID=2] after 12 weeks of treatment
timeFrame: 12 weeks
measure: Proportion of days covered (PDC) Time to discontinuation Reasons for treatment discontinuation
timeFrame: 6 months
measure: Drivers for initiation or switch to BGF MDI via physician questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Baia Mare
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Constanta
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Deva
country: Romania
facility: Research Site
city: Dorohoi
country: Romania
facility: Research Site
city: Hunedoara
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Ludus
country: Romania
facility: Research Site
city: Medgidia
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Sighisoara
country: Romania
facility: Research Site
city: Suceava
country: Romania
facility: Research Site
city: Targu Mures
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
Study officials:
References: