SABINA INTERNATIONAL

NCT03857178 | Completed

• 1 other identifier: D589SR00002
• Study Type: observational
• Target: 8,617
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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): 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

  12 months retrospective from index date

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

San Salvador, Argentina

Location

Related Publications (3)

• Tan DHY, Tan TL, Tan WH, Choong C, Beekman MJHI, Khor JH, Kumar SS, Wong GR, Lim HF. SABA prescriptions and asthma management practices in Singapore: results from a cross-sectional, observational SABINA III study. BMJ Open. 2024 Jun 10;14(6):e064245. doi: 10.1136/bmjopen-2022-064245.

  PMID: 38858145 DERIVED

• Alzaabi A, Al Busaidi N, Pradhan R, Shandy F, Ibrahim N, Ashtar M, Khudadah K, Hegazy K, Samir M, Negm M, Farouk H, Al Khalidi A, Beekman M. Over-prescription of short-acting beta2-agonists and asthma management in the Gulf region: a multicountry observational study. Asthma Res Pract. 2022 Jul 7;8(1):3. doi: 10.1186/s40733-022-00085-5.

  PMID: 35799290 DERIVED

• Bateman ED, Price DB, Wang HC, Khattab A, Schonffeldt P, Catanzariti A, van der Valk RJP, Beekman MJHI. Short-acting beta2-agonist prescriptions are associated with poor clinical outcomes of asthma: the multi-country, cross-sectional SABINA III study. Eur Respir J. 2022 May 5;59(5):2101402. doi: 10.1183/13993003.01402-2021. Print 2022 May.

  PMID: 34561293 DERIVED

Related Links

• This is the CSR of the study.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: March 29, 2019
• Primary Completion: May 6, 2020
• Study Completion: May 6, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

AR (1)