AsthmaNCT03857178
SABINA INTERNATIONAL
An observational study of Asthma, run by AstraZeneca at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- How many people
- 8,617 participants
- Where
- 1 siteArgentina
- Study dates
- 29 Mar 2019to 6 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months retrospective from index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start29 Mar 2019
- Primary completion6 May 2020
- Study completion6 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 8,617 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857178
- Sponsor's protocol ID
- D589SR00002
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2019
- Last updated
- 11 Feb 2021
- Results posted
- No
Publications
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.
PubMed 38858145Alzaabi 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.
PubMed 35799290Bateman 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.
PubMed 34561293
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03857178
- Acronym / sponsor ID
- D589SR00002
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,617 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 6 May 2020 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Derived from this study: PubMed 38858145Tan 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.
- Derived from this study: PubMed 35799290Alzaabi 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.
- Derived from this study: PubMed 34561293Bateman 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.
- This is the CSR of the study.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main outcome will be a categorisation of SABA prescription in asthma patients. (time frame: 12 months retrospective from index date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03857178, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.