Submitted by: Erica Frances Garcia 2019-05-22 01:59:06 Last Updated by: Principe, Jeverly Ann S 2019-05-31 16:46:49 Export to PDF

SABA in Asthma International (SABINA-International)  

PHRR190531-002146

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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

 (SABA in Asthma International SABINA-International)

An observational, multi-country, multi center, cross sectional study describing SABA prescription and potential effects among asthma patients, using real-time electronic data collection methods in local health care settings

Start Date Duration in Months Target Completion Date Actual Completion Date
2019-05-20 12 2020-05-20 2019-05-22

Ongoing

Institution Classification Region LTO #
AstraZeneca Pharmaceuticals (Philippines) Inc. Private Business NCR
Institution Amount Region
AstraZeneca Pharmaceuticals (Philippines) Inc. N/A NCR
Name Expertise Affiliation
Dina V. Diaz, MD Principal Investigator Lung Center of the Philippines
Ronnie Z. Samoro, MD Principal Investigator HealthLink Iloilo Inc.
Jessie Orcasitas, MD Principal Investigator Metro Davao Medical and Research Center

Asthma is a common chronic disease globally, and mild asthma is highly prevalent within asthma populations (Bloom et al. 2017; Dusser et al. 2007; Selroos et al. 2015; To et al. 2012). The 2017 Global Initiative for Asthma (GINA), recommend and define pharmacological stepwise approaches to managing asthma patients (Global Initiative for Asthma 2017). These stepwise approaches progress with increasing medication dosage, and classes of drugs, to achieve good asthma control. For example, mild asthma patients are treated according to steps 1 and 2; step 1 is the prescription of only SABA to be used as a reliever as symptoms dictate, this is stepped up to include a regular low dose inhaled corticosteroids (ICS) in step 2. At each step patients can use a reliever medication as well as their controller medication(s) for acute worsening of symptoms. However, there is an increasing view that as the underlying process contributing towards these symptomatic episodes is worsening inflammation, first-line treatment should always be with an anti-inflammatory medication (such as ICS), rather than purely symptom-management with a bronchodilator (Pavord et al. 2017; O’Byrne et al. 2017). Under-prescription of low dose ICS and over-prescription  of SABA among asthma patients is a common problem which unnecessarily increases healthcare resource utilisation (HRU) and morbidity (Laforest et al. 2015; FitzGerald et al. 2017; Barnes & Ulrik 2015).

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

 

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Recruiting

Non-clinical Studies

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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

  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.

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  Primary Objective(s)

The primary objective is to determine the pattern and trend of SABA prescriptions in a population of asthma patients across various countries, selected in a cross-sectional manner.

Specific objectives will be:

  1. Describe the demographic and clinical features of the asthma population selected in each site and by HCP using GINA steps 1 and 2 (mild) and steps 3-5 (moderate/severe) (Figure 1).
  2. Estimate SABA prescriptions per patient (by canisters per year) and describe the patients within the different SABA groups.
  3. Estimate ICS prescriptions per patient (by average daily dose) and describe the patients within the different ICS groups.

 Secondary Objective(s)

 The secondary objectives will be to determine how health outcomes are associated with the prescription of SABA. 

  1. Describe the relation between SABA use and prevalent symptoms (GINA assessment of asthma control).
  2. Describe the relation between SABA use and number of severe exacerbations, leading to either a hospitalization or ER visit, related to asthma in the past 12 months per patient.

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20 May 2019

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