Ignite Creation Date:
2024-07-17 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472310
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-22
Brief Title:
Clinical and demOgRaphic Features of Patients With Uncontrolled Severe Asthma in Russia CORSAR
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
An Observational Multicenter Cross-sectional Study of Patients With Uncontrolled Severe Asthma in the Population of the Russian Federation
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CORSAR
Brief Summary:
This study is an observational multicenter cross-sectional study Planned study population consists of 5 000 adult patients with uncontrolled SA receiving treatment according to standard of care except biologics Planned number of study site is 50 outpatient centers with experience of uncontrolled SA treatment in about 50 regions of Russia in order to describe characteristics of patients with uncontrolled SA in different regions in the most comprehensive way This non-interventional study does not imply any intervention into a routine clinical practice and does not provide for any diagnostic and therapeutic procedures other than those used in routine practice
Detailed Description:
There are limited epidemiological data of the patients with uncontrolled severe asthma in Russia since there is no unified system for regular monitoring of patients with severe asthma in the country The systematic information about complications and comorbidities about the treatment approaches and their effectiveness in the Russian population is also absent
The observational registry is really important to describe the epidemiological characteristics of the disease and to analyse the clinical characteristics of the various subgroups of patients This is an excellent starting point to be able to investigate the characteristics of the disease in detail
The Russian Federation consists of 85 regions with a total population of more than 145 million people The regions differ in ethnic composition age gender climate ecology economic level prevalence of asthma in general and severe asthma in particular
Previously reported observational registries are International Severe Asthma Registry ISAR and Russian Severe Asthma Registry RSAR both studies included patients regardless of whether patients received biological agents or not The percentage of patients receiving biologics in these studies was 254 and 106 respectively
Thus there is a need to perform a large-scale observational registry in regions of the country with a sufficient size of population to obtain information on SA epidemiology clinical and demographic characteristics to describe main clinical outcomes and evaluate existing associations between observed treatment patterns and clinical outcomes in real clinical practice in patients with uncontrolled SA not receiving biologic therapy
Trial will have cross-sectional design and will include 1 visit for obtaining the patients demographic and clinical data To allow wide data coverage the study will involve at least 50 regions of Russian Federation in each region 100 patients will be recruited The total size of study population will be 5 000 patients
The observational registry is really important to describe the epidemiological characteristics of the disease and to analyse the clinical characteristics of the various subgroups of patients This is an excellent starting point to be able to investigate the characteristics of the disease in detail
The Russian Federation consists of 85 regions with a total population of more than 145 million people The regions differ in ethnic composition age gender climate ecology economic level prevalence of asthma in general and severe asthma in particular
Previously reported observational registries are International Severe Asthma Registry ISAR and Russian Severe Asthma Registry RSAR both studies included patients regardless of whether patients received biological agents or not The percentage of patients receiving biologics in these studies was 254 and 106 respectively
Thus there is a need to perform a large-scale observational registry in regions of the country with a sufficient size of population to obtain information on SA epidemiology clinical and demographic characteristics to describe main clinical outcomes and evaluate existing associations between observed treatment patterns and clinical outcomes in real clinical practice in patients with uncontrolled SA not receiving biologic therapy
Trial will have cross-sectional design and will include 1 visit for obtaining the patients demographic and clinical data To allow wide data coverage the study will involve at least 50 regions of Russian Federation in each region 100 patients will be recruited The total size of study population will be 5 000 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None