Clinical and demOgRaphic Features of Patients With Uncontrolled Severe Asthma in Russia (CORSAR)

Last updated: March 11, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asthma

Treatment

N/A

Clinical Study ID

NCT06472310
D5180R00037
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years at the time of inclusion;

  2. Signed and dated written informed consent in accordance with ICH GCP and local lawprior to inclusion in the study;

  3. 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 isdefined as asthma, that is controlled due to treatment with ICS in medium or highdoses 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 leadto 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.

  4. Patients with the availability of at least 52 weeks of follow-up data (prior toinclusion) in the medical records.

Exclusion

Exclusion Criteria:

  1. Patients receiving any biological therapy currently or within 52 weeks prior toinclusion;

  2. Presence of chronic obstructive pulmonary disease (COPD) or idiopathic pulmonaryfibrosis (ILF) currently or in the anamnesis;

  3. The participation in any clinical study currently or within 52 weeks prior toinclusion;

  4. An acute or chronic disease that, as deemed by Investigator, limits the ability ofpatients to participate in this study or could influence the interpretation of theresults.

Study Design

Total Participants: 5000
Study Start date:
June 06, 2024
Estimated Completion Date:
June 30, 2027

Study 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 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.

Connect with a study center

  • Research Site

    Astrakhan,
    Russian Federation

    Active - Recruiting

  • Research Site

    Barnaul,
    Russian Federation

    Active - Recruiting

  • Research Site

    Blagoveshchensk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Bryansk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Chelyabinsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Ekaterinburg,
    Russian Federation

    Active - Recruiting

  • Research Site

    Irkutsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Kazan,
    Russian Federation

    Active - Recruiting

  • Research Site

    Khabarovsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Krasnodar,
    Russian Federation

    Active - Recruiting

  • Research Site

    Krasnoyarsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Moscow,
    Russian Federation

    Active - Recruiting

  • Research Site

    Murmansk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Nalchik,
    Russian Federation

    Active - Recruiting

  • Research Site

    Nizhniy Novgorod,
    Russian Federation

    Active - Recruiting

  • Research Site

    Nizhny Novgorod,
    Russian Federation

    Active - Recruiting

  • Research Site

    Novosibirsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Omsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Orenburg,
    Russian Federation

    Active - Recruiting

  • Research Site

    Petrozavodsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Ryazan,
    Russian Federation

    Active - Recruiting

  • Research Site

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Research Site

    Saint-Petersburg,
    Russian Federation

    Active - Recruiting

  • Research Site

    Samara,
    Russian Federation

    Active - Recruiting

  • Research Site

    Saratov,
    Russian Federation

    Active - Recruiting

  • Research Site

    Smolensk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Stavropol,
    Russian Federation

    Active - Recruiting

  • Research Site

    Tomsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Ufa,
    Russian Federation

    Active - Recruiting

  • Research Site

    Ulan Ude,
    Russian Federation

    Site Not Available

  • Research Site

    Ulan-Ude,
    Russian Federation

    Active - Recruiting

  • Research Site

    Verkhnyaya Pyshma,
    Russian Federation

    Active - Recruiting

  • Research Site

    Vladimir,
    Russian Federation

    Active - Recruiting

  • Research Site

    Vladivostok,
    Russian Federation

    Active - Recruiting

  • Research Site

    Volgograd,
    Russian Federation

    Active - Recruiting

  • Research Site

    Voronezh,
    Russian Federation

    Active - Recruiting

  • Research Site

    Yekaterinburg,
    Russian Federation

    Active - Recruiting

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