Clinical and demOgRaphic Features of Patients With Uncontrolled Severe Asthma in Russia (CORSAR)
An Observational Multicenter Cross-sectional Study of Patients With Uncontrolled Severe Asthma in the Population of the Russian Federation
AstraZeneca
5,000 participants
Jun 6, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Age ≥ 18 years at the time of inclusion;
- Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study;
- Patients with diagnosis of uncontrolled SA (Asthma Control Questionnaire-5 (ACQ-5) score \> 1,5) established no less than 52 weeks prior to inclusion; Severe asthma is defined as asthma, that is controlled due to treatment with ICS in medium or high doses plus LABA and/or ALP, and/or LAMA, and/or systemic corticosteroids (sCS), and/or immunobiological therapy, while attempts to reduce the volume of therapy lead to a loss of symptom control, or asthma remains uncontrolled despite this treatment. Such therapy should be carried out at least 3 months before inclusion.
- Uncontrolled asthma is defined as ACQ-5\>1.5.
- Patients with the availability of at least 52 weeks of follow-up data (prior to inclusion) in the medical records.
Exclusion Criteria4
- Patients receiving any biological therapy currently or within 52 weeks prior to inclusion;
- Presence of chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (ILF) currently or in the anamnesis;
- The participation in any clinical study currently or within 52 weeks prior to inclusion;
- An acute or chronic disease that, as deemed by Investigator, limits the ability of patients to participate in this study or could influence the interpretation of the results.
Locations(40)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06472310