AsthmaNCT03963141
Retrospective Analysis to Describe Patient Profiles, Current Treatment Patterns and Economic Burden for Asthma Patients in UAE. A Descriptive Analysis of the Asthma Patient Population in the Emirate of Dubai With Respect to Healthcare Resource Utilization, Costs, and Asthma-related Treatment Pattern
An observational study of Asthma, run by AstraZeneca at 1 site in United Arab Emirates.
Trial summary
This Retrospective cohort study with an overall objective of to perform a descriptive analysis of the asthma patient population in the Emirate of Dubai with respect to healthcare resource utilization, costs, and asthma-related treatment patterns and outcome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- How many people
- 40,541 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 31 Aug 2019to 31 Oct 2022
- 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: All patients with a diagnosis of asthma during the identification period will be considered for the analysis
Who may be able to join
- Minimum two claims with asthma diagnosis, 30 days apart, during the identification period
- Minimum 12 months of baseline period
- Age ≥ 18 years on the index date
- Continuous enrolment during the baseline period and at least 180 days of follow-up period; enrolment will be defined based on at least one activity during each 90-day period from the index date
Who cannot join
- Diagnosis of COPD during the baseline period. Diagnosis of COPD will be defined as ≥1 medical claim with an ICD-10 diagnosis in any position
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis to Describe Patient Profiles, Current Treatment Patterns and Economic Burden for Asthma Patients in UAE.
This Retrospective cohort study with an overall objective of to perform a descriptive analysis of the asthma patient population in the Emirate of Dubai with respect to healthcare resource utilization, costs, and asthma-related treatment patterns and outcome.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Patients Number
Number of unique asthma patients in the database during December 2015 through November 2018(summarized annually).it will be computed in the follow-up period and will be reported as a percentage and number of visits per person per year (PPPY). Utilization will be considered "all-cause" if the associated medical claim(s) has a diagnosis code in any position for any condition.
Measured: 1 Year
Asthma-related Cost
Total asthma-related cost reported in the databse during December 2015 through November 2018(summarized annually).It will will be computed in the follow-up period and will be reported as a percentage and number of visits per person per year (PPPY). Utilization will be considered "asthma-related" if the associated medical claim(s) has ICD-10 diagnosis code for asthma as the principal diagnosis
Measured: 1 Year
Secondary outcomes (3)
Asthma-related hopitalizations cost
Number of asthma related hopistalizations and cost reported in the database during December 2015 through Novemebr 2018(Summairzed annually)
Measured: 1 Year
Astma-related prescription pattern
Prescription pattern of asthma-related medication by drug class during December 2015 through November 2018
Measured: 1 Year
Severity of Asthma per total number of patients
Number of patients classified as Mild, moderate and severe asthmatic patinets as per the international guidlines.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start31 Aug 2019
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 40,541 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963141
- Sponsor's protocol ID
- D2287R00139
- Status last verified
- May 2024
- First submitted
- 3 Apr 2019
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis to Describe Patient Profiles, Current Treatment Patterns and Economic Burden for Asthma Patients in UAE.
- ClinicalTrials.gov ID
- NCT03963141
- Acronym / sponsor ID
- D2287R00139
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40,541 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 24 May 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.
This Retrospective cohort study with an overall objective of to perform a descriptive analysis of the asthma patient population in the Emirate of Dubai with respect to healthcare resource utilization, costs, and asthma-related treatment patterns and outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with a diagnosis of asthma during the identification period will be considered for the analysis
Key inclusion criteria (4 listed)
- Minimum two claims with asthma diagnosis, 30 days apart, during the identification period
- Minimum 12 months of baseline period
- Age ≥ 18 years on the index date
- Continuous enrolment during the baseline period and at least 180 days of follow-up period; enrolment will be defined based on at least one activity during each 90-day period from the index date
Key exclusion criteria (1 listed)
- Diagnosis of COPD during the baseline period. Diagnosis of COPD will be defined as ≥1 medical claim with an ICD-10 diagnosis in any position
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
Asthma Patients Number
Time frame: 1 Year
Number of unique asthma patients in the database during December 2015 through November 2018(summarized annually).it will be computed in the follow-up period and will be reported as a percentage and number of visits per person per year (PPPY). Utilization will be considered "all-cause" if the associated medical claim(s) has a diagnosis code in any position for any condition.
Asthma-related Cost
Time frame: 1 Year
Total asthma-related cost reported in the databse during December 2015 through November 2018(summarized annually).It will will be computed in the follow-up period and will be reported as a percentage and number of visits per person per year (PPPY). Utilization will be considered "asthma-related" if the associated medical claim(s) has ICD-10 diagnosis code for asthma as the principal diagnosis
3 secondary outcomes
Asthma-related hopitalizations cost
Time frame: 1 Year
Astma-related prescription pattern
Time frame: 1 Year
Severity of Asthma per total number of patients
Time frame: 1 Year
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 21 May 2024.
- CSR SynopsisLink 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 United Arab Emirates.
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 1 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 21 May 2024. 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 United Arab Emirates. 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?
Asthma Patients Number (time frame: 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2024.