A Clinical Study to Evaluate the Efficacy and Safety of Frevecitinib (KN-002) in Patients With Severe Asthma
NCT07532265
Asthma, Bronchial Diseases
Lancaster, California, United States
View Trial DetailsNCT Number: NCT06472310
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Research Site, Astrakhan, Russia
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 25.4% and 10.6% 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 patient's 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Uncontrolled asthma is defined as ACQ-5>1.5.
Exclusion criteria
Time frame: June 2024 - June 2027
a. Short-acting beta-agonists (SABA) (duration, dosage); b. LAMA (duration, dosage); c. LTRA (duration, dosage); d. Theophylline (duration, dosage); e. Macrolide antibiotics (duration, dosage).
Time frame: June 2024 - June 2027
Proportion of patients receiving OCS: intermittent/regularly; Median daily dose in case of regular OCS use; Median cumulative OCS exposure.
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
BMI ≥25 kg/m2
Time frame: June 2024 - June 2027
educational statuses: higher, secondary special, secondary general
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
Proportion of patients with chronic rhinosinusitis with nasal polyps (CRSwNP), overall proportion and:
a. Proportions of patients with CRSwNP with different levels of eosinophils blood count: i. <150 cells/μl; ii. ≥150 cells/μl; iii. ≥300 cells/μl. b. Proportions of patients with CRSwNP with different levels of total IgE: i. ≤30 UI/ml; ii. >30 UI/ml; c. The proportion of patients with CRSwNP with a history of prior biologic treatment ('any biologic drugs used for asthma treatment in the past'); d. The proportion of patients with CRSwNP who were recommended to start biologic treatment at the first visit ('the need of biological therapy prescription').
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
cells/μl
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
cells per high power field
Time frame: June 2024- June 2027
IU/ml
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
parts per billion (ppb)
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
*Severe asthma exacerbation is defined as worsening of asthma requiring any of the following:
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
Time frame: June 2024 - June 2027
Contact information is provided by the study sponsor or research team.
AstraZeneca
Industry
An Observational Multicenter Cross-sectional Study of Patients With Uncontrolled Severe Asthma in the Population of the Russian Federation
Acronym: CORSAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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