Clinical and demOgRaphic Features of Patients With Uncontrolled Severe Asthma in Russia (CORSAR)
NCT Number: NCT06472310
Acronym: CORSAR
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Severe Asthma
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-06
Completion Date: 2027-06-30
Locations: Research Site, Barnaul, Russian Federation|Research Site, Blagoveshchensk, Russian Federation|Research Site, Kazan, Russian Federation|Research Site, Krasnoyarsk, Russian Federation|Research Site, Moscow, Russian Federation|Research Site, Nalchik, Russian Federation|Research Site, Nizhny Novgorod, Russian Federation|Research Site, Omsk, Russian Federation|Research Site, Orenburg, Russian Federation|Research Site, Saint Petersburg, Russian Federation|Research Site, Samara, Russian Federation|Research Site, Saratov, Russian Federation|Research Site, Tomsk, Russian Federation|Research Site, Ulan Ude, Russian Federation|Research Site, Volgograd, Russian Federation|Research Site, Voronezh, Russian Federation|Research Site, Yekaterinburg, Russian Federation

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.

Primary Outcome Measures: 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 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 overeating;
5. Proportion of patient with physical inactivity., 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, 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 Outcome Measures: 1. Proportion of patients with change of inhaled therapy during retrospective 52-week follow-up period, 1. Change of ICS;
2. Dose of ICS increased;
3. Addition of another drug for inhaled therapy, 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, \*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., June 2024 - June 2027|5. Annualised rate of severe asthma exacerbations* during retrospective 52-week follow-up period, June 2024 - June 2027|6. Cumulative days of severe asthma exacerbations, June 2024 - June 2027|7. Proportion of patients with healthcare resource utilization (HRU) events during retrospective 52-week follow-up period:, 1. Unscheduled outpatient visits;
2. Emergency department visits/emergency calls;
3. Hospitalizations., June 2024 - June 2027|8. Mean parameters of lung function:, 1. Mean pre- and post-bronchodilator forced expiratory volume in 1 second (pre- and post-FEV1);
2. Mean pre- and post-bronchodilator forced vital capacity (pre- and post-FVC);
3. Mean pre-bronchodilator forced expiratory flow (pre-FEF);
4. Mean functional residual capacity (FRC), residual lung volume (RLV) and total lung capacity (TLC) evaluated by spirometry and/or body plethysmography., June 2024 - June 2027