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SABINA INTERNATIONAL

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ClinicalTrials.gov Identifier: NCT03857178
Recruitment Status : Not yet recruiting
First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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
Asthma

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Study Type : Observational
Estimated Enrollment : 7500 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
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma




Primary Outcome Measures :
  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):

    1. No prescriptions for asthma inhalers
    2. Appropriate SABA prescription with no ICS
    3. Appropriate SABA prescription with ICS
    4. SABA over-prescription with no ICS
    5. 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:

    1. Appropriate SABA prescription on top of maintenance therapy
    2. SABA over-prescription on top of maintenance therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The selection of sites and investigators will be made with the aim to achieve representativeness in the way asthma is managed in each participating country. The study will include patients from either primary care centres, or specialist centres involved in the management of asthma, or a mix of both within a country to ensure representativeness.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03857178


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Sponsors and Collaborators
AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03857178     History of Changes
Other Study ID Numbers: D589SR00002
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases