- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03963141
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
May 20, 2024 updated by: AstraZeneca
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
40541
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dubai, United Arab Emirates
- Dha Claim
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All patients with a diagnosis of asthma during the identification period will be considered for the analysis
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
• 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma Patients Number
Time Frame: 1 Year
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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.
|
1 Year
|
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Asthma-related Cost
Time Frame: 1 Year
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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
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma-related hopitalizations cost
Time Frame: 1 Year
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Number of asthma related hopistalizations and cost reported in the database during December 2015 through Novemebr 2018(Summairzed annually)
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1 Year
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Astma-related prescription pattern
Time Frame: 1 Year
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Prescription pattern of asthma-related medication by drug class during December 2015 through November 2018
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1 Year
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Severity of Asthma per total number of patients
Time Frame: 1 Year
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Number of patients classified as Mild, moderate and severe asthmatic patinets as per the international guidlines.
|
1 Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2019
Primary Completion (Actual)
October 31, 2022
Study Completion (Actual)
October 31, 2022
Study Registration Dates
First Submitted
April 3, 2019
First Submitted That Met QC Criteria
May 23, 2019
First Posted (Actual)
May 24, 2019
Study Record Updates
Last Update Posted (Actual)
May 21, 2024
Last Update Submitted That Met QC Criteria
May 20, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D2287R00139
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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