SABINA INTERNATIONAL

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03857178
• Other study ID #: D589SR00002
• Status: Completed
• Start date: March 29, 2019
• Est. completion date: May 6, 2020

Study information

• Verified date: February 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8617
• Est. completion date: May 6, 2020
• Est. primary completion date: May 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Argentina	Research Site	San Salvador

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main outcome will be a categorisation of SABA prescription in asthma patients.	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	12 months retrospective from index date

External Links

•   This is the CSR of the study.