Real-World Effectiveness of a Triple Combination BDP/FF/GB in a Single Pressurised Metered Dose Inhaler in COPD Patients (TRIPHY)

Study Identifier:
CLI-05993AA1-23
ClinicalTrials.gov Identifier:
NCT06480890
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Chronic Obstructive Pulmonary Disease
Study Drug
    Date
    Jul 2024 - Sep 2025
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & Male
    Age: 40+ years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • Subjects who are willing and able to give their written consent to participate in the study
    • Aged ≥40 years at BDP/FF/GB initiation
    • Had documented diagnosis of COPD prior to BDP/FF/GB initiation
    • Baseline CAT total score ≥10 (at the time of BDP/FF/GB initiation OR within the 12 weeks prior to treatment initiation, if no CAT total score is available on BDP/FF/GB initiation date)
    • Subjects who have initiated treatment with BDP/FF/GB within 12 weeks prior to informed consent form (ICF) signature, or on date of ICF signature
    Exclusion Criteria
    • Subjects who had been admitted to hospital for a COPD exacerbation within the last 4 weeks prior to BDP/FF/GB initiation
    • Subjects who are not likely to come back 12-weeks after BDP/FF/GB initiation, per Investigator judgement
    • Participation in any clinical trial in the 4 weeks prior to BDP/FF/GB initiation
    • Subjects had used any other single inhaler triple therapy before or at BDP/FF/GB initiation
    Healthy Volunteers
    No

    Protocol Summary

    The purpose of the study is to evaluate Real-World Effectiveness of a Triple Combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) in a Single Pressurised Metered Dose Inhaler (Trimbow® pMDI) in Subjects with Chronic Obstructive Pulmonary Disease (COPD).

    Study Locations

    Location
    Status
    Location
    Site 156119 - Peking University People's Hospital
    Beijing, Beijing Municipality, China, 100033
    Status
    N/A
    Location
    Site 156110 Beijing Jingmei Group Genetal Hospital
    Beijing, Beijing Municipality, China, 102300
    Status
    N/A
    Location
    Site 156101 - The First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong, China, 510120
    Status
    N/A
    Location
    Site 156113 - The Second Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong, China, 510260
    Status
    N/A
    Location
    Site 156114 - The Second Affiliated Hospital of Guangdong Medical University
    Zhanjiang, Guangdong, China, 524003
    Status
    N/A
    Location
    Site 156108 - Henan Provincial People's Hospital
    Zhengzhou, Henan, China, 450003
    Status
    N/A
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