Clinical& Demographic Profiles of patIents With unControllEd Asthma in Russia: Multi-center oBsErvational ReGistry Study

There are limited epidemiological data of the patients with uncontrolled asthma in Russia. 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 uncontrolled asthma in particular.

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 uncontrolled asthma 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 asthma not receiving biologic therapy.

Trial will have ambispective design and will include 2 visits 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 200 patients will be recruited. The total size of study population will be 9 000 patients.

All data will be collected during 2-3 visits carried out according to routine clinical practice for observation and treatment of patients with uncontrolled asthma. At visit 1, baseline data of 52 weeks prior to inclusion will be collected by physician based on the patient's medical records and interview during the visit. Visit 2 (final visit) will be conducted after 12 weeks (±7 days) in order to collect follow-up data which coincides with the recommended dates. Information on changes in the treatment of uncontrolled asthma and on clinical outcomes will be collected.

For the cohort of patients receiving fixed-dose combination budesonide/salbutamol on Visit 2, an additional follow-up visit (Visit 3) will be conducted in 12 weeks (±14 days) after Visit 2, in order to collect data which coincides with the recommended dates. Information on changes in the treatment of uncontrolled asthma and on clinical outcomes will be collected. It is planned to enroll 500 patients receiving fixed-dose combination budesonide/salbutamol on Visit 2, to whom the follow-up visit (Visit 3) will be conducted.

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.

• 1. Proportion of patients with controlled and partly controlled asthma at visit 2 in all patients and in the cohort of patients receiving FDC budesonide/salbutamol [Time frame: 12 weeks (also 52 weeks of retrospective data before visit 1)]
• 2. Proportion of patients with changes of inhaled asthma therapy occurred from baseline to visit 2 (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) [Time frame: 12 weeks (also 52 weeks of retrospective data before visit 1)]
• 3. Proportion of patients with OCS prescription occurred from baseline to visit 2 (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) [Time frame: 12 weeks (also 52 weeks of retrospective data before visit 1)]
• 4. Proportion of patients with ICS-containing therapy as reliever and as maintenance at visit 2 [Time frame: 12 weeks (also 52 weeks of retrospective data before visit 1)]
• 5. Proportion of patients using SABA reliever for symptoms more than two times a week at visit 2 (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) [Time frame: 12 weeks (also 52 weeks of retrospective data before visit 1)]
• 6. Proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) [Time frame: during 52 weeks prior to inclusion]
• 7. Annualised rate of severe asthma exacerbations (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) [Time frame: during 52 weeks prior to inclusion]
• 8. Cumulative days of severe asthma exacerbations (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) [Time frame: during 52 weeks prior to inclusion]
• 9. Proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) [Time frame: 12 weeks]
• 10. Proportion of patients with healthcare resource utilization (HRU) events (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) [Time frame: during 52 weeks prior to inclusion]
• 11. Proportion of patients with HRU events (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) [Time frame: 12 weeks]
• 12.a Change from baseline in mean parameters of lung function at visit 2 (in case of availability of spirometry data) in all patients and in the cohort of patients receiving FDC budesonide/salbutamol [Time frame: 12 weeks]