Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521229
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-21
Brief Title:
Clinical Demographic Profiles of patIents With unControllEd Asthma in Russia Multi-center oBsErvational ReGistry Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Ambispective Observational Multicenter Registry of Patients With Uncontrolled Asthma in the Population of the Russian Federation
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICEBERG
Brief Summary:
This study is a multi-centre non-interventional observational ambispective registry Planned study population consists of 10 000 adult patients with uncontrolled asthma receiving treatment according to standard of care except biologics Planned number of study site is 70 outpatient centers with experience of uncontrolled asthma treatment in about 50 regions of Russia in order to describe characteristics of patients with uncontrolled asthma in different regions in the most comprehensive way
Detailed Description:
There are limited epidemiological data of the patients with uncontrolled asthma in Russia 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 uncontrolled asthma in particular
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 uncontrolled asthma 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 asthma not receiving biologic therapy
Trial will have ambispective design and will include 2 visits 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 200 patients will be recruited The total size of study population will be 10 000 patients
All data will be collected during 2 visits carried out according to routine clinical practice for observation and treatment of patients with uncontrolled asthma At visit 1 baseline data of 52 weeks prior to inclusion will be collected by physician based on the patients medical records and interview during the visit Visit 2 final visit will be conducted after 3 months in order to collect follow-up data which coincides with the recommended dates Information on changes in the treatment of uncontrolled asthma and on clinical outcomes will be collected
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
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 uncontrolled asthma in particular
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 uncontrolled asthma 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 asthma not receiving biologic therapy
Trial will have ambispective design and will include 2 visits 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 200 patients will be recruited The total size of study population will be 10 000 patients
All data will be collected during 2 visits carried out according to routine clinical practice for observation and treatment of patients with uncontrolled asthma At visit 1 baseline data of 52 weeks prior to inclusion will be collected by physician based on the patients medical records and interview during the visit Visit 2 final visit will be conducted after 3 months in order to collect follow-up data which coincides with the recommended dates Information on changes in the treatment of uncontrolled asthma and on clinical outcomes will be collected
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None