Study on Patterns of Care in Mild Asthmatic Patients

Study Identifier:
CLI-01535AA0-01
ClinicalTrials.gov Identifier:
NCT04598555
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Trial Documents

Clinical Study Report
Available Languages: English
Download document(s)

Study Details

Medical Condition
  • Asthma
Study Drug
    Date
    Feb 2021 - Sep 2022
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & Male
    Age: 18 - 75 Years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • Adult subject (aged ≥ 18 years) up to 75 years
    • Subject with confirmed asthma diagnosis
    • Subject in treatment for mild asthma with Step 1 or Step 2 according to GINA report
    • Subject with written privacy and study informed consent
    Exclusion Criteria
    • Subject enrolled in experimental (interventional) clinical trials, or receiving experimental treatments in the prior 3 months
    • Known pregnant or breast-feeding subject
    • Subject unable to understand and autonomously fill in questionnaires
    • Subject unable to use electronic devices to fill in e-diary, or without compatible electronic devices with access to the Internet
    • Subject who had asthma exacerbation(s) in the past 4 weeks prior to study entry
    • Subject with confirmed Chronic Obstructive Pulmonary Disease
    Healthy Volunteers
    No

    Protocol Summary

    The PRIME study is an observational, Real World Evidence study designed to collect the type of treatments that are currently prescribed to patients with mild asthma and to collect relevant clinical data that could reflect the control of the disease over a 6-month observational period according to the standard clinical practice.

    Study Locations

    Location
    Status
    Location
    DE-008 Lungenarztpraxis Hellersdorf
    Berlin, Germany
    Status
    N/A
    Location
    DE-003 Praxis Pneumologie und Allergologie Dr. Ginko
    Bonn, Germany
    Status
    N/A
    Location
    DE-005 Praxis für Pneumologie und Innere Medizin
    Fürstenwalde, Germany
    Status
    N/A
    Location
    DE-006 Studieninstitut des Pneumologicums Halle
    Halle, Germany
    Status
    N/A
    Location
    DE-001 Salvus - Klinische Studien GmbH
    Leipzig, Germany
    Status
    N/A
    Location
    DE-007 POIS Leipzig GbR
    Leipzig, Germany
    Status
    N/A
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