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OpenTrials
Completed

NCT Number: NCT03857178

SABINA INTERNATIONAL

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

San Salvador, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients ≥12 years-old
  • Documented diagnosis with Asthma as per medical records.
  • Have had ≥3 consultations with the HCP at study start date
  • 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

  • Patient with a diagnosis of chronic obstructive pulmonary disease or other chronic respiratory disease different from Asthma.
  • An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in this study

Treatment and study plan

Primary outcomes

  1. The main outcome will be a categorisation of SABA prescription in asthma patients.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2019
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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