Clinical and demOgRaphic Features of Patients With Uncontrolled Severe Asthma in Russia (CORSAR)
CORSAR
An Observational Multicenter Cross-sectional Study of Patients With Uncontrolled Severe Asthma in the Population of the Russian Federation
1 other identifier
observational
5,000
1 country
37
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
Typical duration for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2024
CompletedStudy Start
First participant enrolled
June 6, 2024
CompletedFirst Posted
Study publicly available on registry
June 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
May 7, 2026
May 1, 2026
3.1 years
May 22, 2024
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (19)
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
1. ICS alone (duration, dosage); 2. LABA alone (duration, dosage); 3. ICS and LABA (duration, dosage); 4. 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).
June 2024 - June 2027
To determine the pattern and trends of OCS prescription
Proportion of patients receiving OCS: intermittent/regularly; Median daily dose in case of regular OCS use; Median cumulative OCS exposure.
June 2024 - June 2027
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
June 2024 - June 2027
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
June 2024 - June 2027
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
June 2024 - June 2027
To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of men and women will be calculated
June 2024 - June 2027
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
June 2024 - June 2027
To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with overweight will be calculated
BMI ≥25 kg/m2
June 2024 - June 2027
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
educational statuses: higher, secondary special, secondary general
June 2024 - June 2027
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
June 2024 - June 2027
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
1. Proportion of patients with history of smoking/current smokers; 2. Mean smoking index (pack-years) for current smokers; 3. Proportion of patients with a history of alcohol abuse/current alcohol abuse; 4. Proportion of patients with limitation of physical activity, related/non-related to asthma; 5. Proportion of patients with overweight (BMI ≥25 kg/m2).
June 2024 - June 2027
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
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').
June 2024 - June 2027
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
June 2024 - June 2027
To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean eosinophils blood count will be collected
cells/μl
June 2024 - June 2027
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
1. \<150 cells/μl; 2. ≥150 cells/μl; 3. ≥300 cells/μl.
June 2024 - June 2027
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
cells per high power field
June 2024 - June 2027
To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation 15. Mean total Immunoglobulin E will be calculated
IU/ml
June 2024- June 2027
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
1. ≤30 UI/ml; 2. \>30 UI/ml;
June 2024 - June 2027
To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean FeNO will be calculated
parts per billion (ppb)
June 2024 - June 2027
Secondary Outcomes (8)
1. Proportion of patients with change of inhaled therapy during retrospective 52-week follow-up period
June 2024 - June 2027
2. Proportion of patients with OCS prescription occurred during retrospective 52-week follow-up period
June 2024 - June 2027
3. Proportion of participants sent to biological therapy
June 2024 - June 2027
4. Proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations* during retrospective 52-week follow-up period
June 2024 - June 2027
5. Annualised rate of severe asthma exacerbations* during retrospective 52-week follow-up period
June 2024 - June 2027
- +3 more secondary outcomes
Eligibility Criteria
5 000 adult patients with confirmed diagnosis of uncontrolled SA who receive medical treatment (excluding biological therapy) and are monitored and treated by pulmonologists or allergologists in approximately 50 clinical centers in about 50 regions of Russia
You may qualify if:
- Uncontrolled asthma is defined as ACQ-5\>1.5.
You may not qualify if:
- Presence of chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (ILF) currently or in the anamnesis;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (37)
Research Site
Astrakhan, Russia
Research Site
Barnaul, Russia
Research Site
Blagoveshchensk, Russia
Research Site
Bryansk, Russia
Research Site
Chelyabinsk, Russia
Research Site
Gatchina, Russia
Research Site
Irkutsk, Russia
Research Site
Izhevsk, Russia
Research Site
Kazan', Russia
Research Site
Kemerovo, Russia
Research Site
Khabarovsk, Russia
Research Site
Krasnodar, Russia
Research Site
Krasnoyarsk, Russia
Research Site
Moscow, Russia
Research Site
Murmansk, Russia
Research Site
Nal'chik, Russia
Research Site
Nizhny Novgorod, Russia
Research Site
Novosibirsk, Russia
Research Site
Omsk, Russia
Research Site
Orenburg, Russia
Research Site
Petrozavodsk, Russia
Research Site
Rostov-on-Don, Russia
Research Site
Ryazan, Russia
Research Site
Saint Petersburg, Russia
Research Site
Samara, Russia
Research Site
Saratov, Russia
Research Site
Stavropol, Russia
Research Site
Tomsk, Russia
Research Site
Ufa, Russia
Research Site
Ulan-Ude, Russia
Research Site
Verkhnyaya Pyshma, Russia
Research Site
Vladimir, Russia
Research Site
Vladivostok, Russia
Research Site
Volgograd, Russia
Research Site
Voronezh, Russia
Research Site
Yakutsk, Russia
Research Site
Yekaterinburg, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2024
First Posted
June 25, 2024
Study Start
June 6, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
May 7, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.