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SABINA INTERNATIONAL

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT03857178
Collaborator
(none)
8,617
Enrollment
1
Location
13.3
Actual Duration (Months)
649.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to describe the prescribing pattern of the different types of medications which are used to treat asthma, across multiple countries.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    8617 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    A Multi-country Study on the Prescription Patterns of Short Acting Beta-2 Agonist (SABA) and Its Potential Effects on Asthma Control: A Cross-Sectional Study on SABA Use in Asthma
    Actual Study Start Date :
    Mar 29, 2019
    Actual Primary Completion Date :
    May 6, 2020
    Actual Study Completion Date :
    May 6, 2020

    Outcome Measures

    Primary Outcome Measures

    1. The main outcome will be a categorisation of SABA prescription in asthma patients. [12 months retrospective from index date]

      Mild asthma patients will be categorised into 5 groups according to the number of SABA and ICS prescriptions in the 12 months prior to their index date (initial exposure window): No prescriptions for asthma inhalers Appropriate SABA prescription with no ICS Appropriate SABA prescription with ICS SABA over-prescription with no ICS SABA over-prescription with ICS Moderate/severe asthma patients will be categorised into 2 groups according to the number of SABA and ICS prescriptions in the 12 months prior to their index date: Appropriate SABA prescription on top of maintenance therapy SABA over-prescription on top of maintenance therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male and female patients ≥12 years-old

    2. Documented diagnosis with Asthma as per medical records.

    3. Have had ≥3 consultations with the HCP at study start date

    4. After full explanation, a patient or legal guardian 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:

    1. Patient with a diagnosis of chronic obstructive pulmonary disease or other chronic respiratory disease different from Asthma.

    2. An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site San Salvador Argentina

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT03857178
    Other Study ID Numbers:
    • D589SR00002
    First Posted:
    Feb 27, 2019
    Last Update Posted:
    Feb 11, 2021
    Last Verified:
    Feb 1, 2021
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Feb 11, 2021