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

Last updated: April 14, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Emphysema

Bronchiectasis

Lung Disease

Treatment

budesonide / glycopyrronium / formoterol

Clinical Study ID

NCT06368427
D5980R00100
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Physician-diagnosed COPD

  • Initiated treatment with BGF MDI as prescribed according to the summary of productcharacteristics (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 documentindicating that they understand the purpose of, and the procedures required for thestudy and are willing to participate in the study

Exclusion

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 theassessment for the current study

  • Participation in a non-interventional, observational trial that might, in theinvestigator's opinion, influence the assessment for the current study, orparticipation in any interventional clinical trial in the last 30 days prior tobaseline.

  • Hospitalization for Covid-19 infection in the last 30 days prior to index date

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: budesonide / glycopyrronium / formoterol
Phase:
Study Start date:
April 30, 2024
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Research Site

    Baia Mare,
    Romania

    Active - Recruiting

  • Research Site

    Bucuresti,
    Romania

    Site Not Available

  • Research Site

    Cluj-Napoca,
    Romania

    Active - Recruiting

  • Research Site

    Constanta,
    Romania

    Active - Recruiting

  • Research Site

    Craiova,
    Romania

    Active - Recruiting

  • Research Site

    Deva,
    Romania

    Active - Recruiting

  • Research Site

    Dorohoi,
    Romania

    Active - Recruiting

  • Research Site

    Hunedoara,
    Romania

    Active - Recruiting

  • Research Site

    Iasi,
    Romania

    Active - Recruiting

  • Research Site

    Ludus,
    Romania

    Active - Recruiting

  • Research Site

    Medgidia,
    Romania

    Site Not Available

  • Research Site

    Oradea,
    Romania

    Active - Recruiting

  • Research Site

    Sighisoara,
    Romania

    Active - Recruiting

  • Research Site

    Suceava,
    Romania

    Active - Recruiting

  • Research Site

    Targu Mures,
    Romania

    Active - Recruiting

  • Research Site

    Timisoara,
    Romania

    Active - Recruiting

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