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NCT Number: NCT06472310

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Astrakhan, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. To characterise the profile of routine therapy used for patients with uncontrolled SA not receiving biological therapy in proportion of patients receiving different classes of drugs will be calculated

    Time frame: June 2024 - June 2027

    • ICS alone (duration, dosage);
    • LABA alone (duration, dosage);
    • ICS and LABA (duration, dosage);
    • ICS and LABA plus:

    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).

  2. To determine the pattern and trends of OCS prescription

    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.

  3. To describe clinical and demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the inclusion into the study will be collected

    Time frame: June 2024 - June 2027

  4. To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the primary asthma diagnosis will be collected

    Time frame: June 2024 - June 2027

  5. To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the diagnosis of SA will be collected

    Time frame: June 2024 - June 2027

  6. To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of men and women will be calculated

    Time frame: June 2024 - June 2027

  7. To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation data on mean body mass index (BMI) will be collected

    Time frame: June 2024 - June 2027

  8. To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with overweight will be calculated

    Time frame: June 2024 - June 2027

    BMI ≥25 kg/m2

  9. To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation data on proportion of patients with different educational statuses

    Time frame: June 2024 - June 2027

    educational statuses: higher, secondary special, secondary general

  10. To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in proportion of patients from each residential region of Russia will be calculated

    Time frame: June 2024 - June 2027

  11. To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with negative lifestyle factors will be calculated

    Time frame: June 2024 - June 2027

    • Proportion of patients with history of smoking/current smokers;
    • Mean smoking index (pack-years) for current smokers;
    • Proportion of patients with a history of alcohol abuse/current alcohol abuse;
    • Proportion of patients with limitation of physical activity, related/non-related to asthma;
    • Proportion of patients with overweight (BMI ≥25 kg/m2).
  12. To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with chronic rhinosinusitis with nasal polyps will be calculated

    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').

  13. To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with different comorbidities will be calculated

    Time frame: June 2024 - June 2027

  14. To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean eosinophils blood count will be collected

    Time frame: June 2024 - June 2027

    cells/μl

  15. To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with different levels of eosinophils blood count will be calculated

    Time frame: June 2024 - June 2027

    • <150 cells/μl;
    • ≥150 cells/μl;
    • ≥300 cells/μl.
  16. To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation 14. Mean eosinophils count in sputum will be collected

    Time frame: June 2024 - June 2027

    cells per high power field

  17. To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation 15. Mean total Immunoglobulin E will be calculated

    Time frame: June 2024- June 2027

    IU/ml

  18. To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with different levels of total IgE will be calculated

    Time frame: June 2024 - June 2027

    • ≤30 UI/ml;
    • >30 UI/ml;
  19. To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean FeNO will be calculated

    Time frame: June 2024 - June 2027

    parts per billion (ppb)

Secondary outcomes

  1. 1. Proportion of patients with change of inhaled therapy during retrospective 52-week follow-up period

    Time frame: June 2024 - June 2027

    • Change of ICS;
    • Dose of ICS increased;
    • Addition of another drug for inhaled therapy
  2. 2. Proportion of patients with OCS prescription occurred during retrospective 52-week follow-up period

    Time frame: June 2024 - June 2027

  3. 3. Proportion of participants sent to biological therapy

    Time frame: June 2024 - June 2027

  4. 4. Proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations* during retrospective 52-week follow-up period

    Time frame: June 2024 - June 2027

    *Severe asthma exacerbation is defined as worsening of asthma requiring any of the following:

    • use of systemic corticosteroids (CS) (or a temporary increase in a stable OCS background dose) for at least 3 days or a single depo-injectable dose of CS and/or
    • an emergency room/urgent care visit (defined as evaluation and treatment for < 24 hours in an emergency department or urgent care center) due to asthma that required systemic CS (as per above) and/or
    • an inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥ 24 hours) due to asthma.
  5. 5. Annualised rate of severe asthma exacerbations* during retrospective 52-week follow-up period

    Time frame: June 2024 - June 2027

  6. 6. Cumulative days of severe asthma exacerbations

    Time frame: June 2024 - June 2027

  7. 7. Proportion of patients with healthcare resource utilization (HRU) events during retrospective 52-week follow-up period:

    Time frame: June 2024 - June 2027

    • Unscheduled outpatient visits;
    • Emergency department visits/emergency calls;
    • Hospitalizations.
  8. 8. Mean parameters of lung function:

    Time frame: June 2024 - June 2027

    • Mean pre- and post-bronchodilator forced expiratory volume in 1 second (pre- and post-FEV1);
    • Mean pre- and post-bronchodilator forced vital capacity (pre- and post-FVC);
    • Mean pre-bronchodilator forced expiratory flow (pre-FEF);
    • Mean functional residual capacity (FRC), residual lung volume (RLV) and total lung capacity (TLC) evaluated by spirometry and/or body plethysmography.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Observational Multicenter Cross-sectional Study of Patients With Uncontrolled Severe Asthma in the Population of the Russian Federation

Acronym: CORSAR

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2024
Registry last updated
Jun 24, 2026

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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