This study is a multi-centre, non-interventional, observational, ambispective registry. Planned study population consists of 9 000 adult patients with uncontrolled asthma receiving treatment according to standard of care (except biologics). Planned number of study site is 70 outpatient centers with experience of uncontrolled asthma treatment in about 50 regions of Russia (in order to describe characteristics of patients with uncontrolled asthma in different regions in the most comprehensive way).
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 mild and moderate asthma (according to Global Initiative for Asthma (GINA) score);
Patients with the availability of at least 52 weeks of follow-up data (prior to inclusion) in the medical records.
Patients with severe asthma or/and 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.
10 000 adult patients with confirmed diagnosis of uncontrolled mild and moderate asthma who receive medical treatment (excluding biological therapy) and are monitored and treated by pulmonologists or allergologists in approximately 70 clinical centers in about 50 regions of Russia
Case-control
Other
Not listed
To describe the baseline demographic characteristics of outpatients with uncontrolled asthma in the Russian Federation in all patients and in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2
1. Mean age at the inclusion into the study; 2. Mean age at the primary asthma diagnosis; 3. Proportion of men and women; 4. Mean body mass index (BMI); 5. Proportion of patients with overweight (BMI ≥25 kg/m2); 6. Proportion of patients with each educational status (higher, secondary special, secondary general); 7. Proportion of patients from each residential region of Russia; 8. Proportion of patients with negative lifestyle factors: 1. Proportion of patients with history of smoking/current smokers - applicable to smoking tobacco and electronic cigarettes (vapes); 2. Mean smoking index (pack-years) for current (tobacco) smokers; 3. Mean duration of smoking (years) for current e-cigarette (vape) smokers; 4. Proportion of patients with a history of alcohol abuse/current alcohol abuse; 5. Proportion of patient with limitation of physical activity. 9. Proportion of patients with chronic rhinosinusitis with nasal polyps; 10. Proportion of patients with different comorbidities
To describe the baseline clinical characteristics of outpatients with uncontrolled asthma in the Russian Federation in all patients and in the cohort of patients receiving FDC budesonide/salbutamol on Visit 2
16\. Mean FeNO (parts per billion (ppb)) (in case of availability of laboratory data)
To characterise the profile of routine therapy used for outpatients with uncontrolled asthma in the Russian Federation in all patients and in the cohort of patients receiving FDC budesonide/salbutamol on Visit 2
17\. Proportion of patients receiving different classes of drugs for treatment of asthma as reliever and maintenance therapy: 1. SABA alone; 2. ICS alone; 3. LABA alone; 4. ICS and LABA; 5. ICS and SABA; 6. ICS and LABA plus: a) SABA; b) LAMA; c) LTRA; d) Theophylline; e) Macrolide antibiotics. f) ICS and LABA (MART therapy) 18. Proportion of patients with ICS-containing therapy as reliever and as maintenance at baseline; 19. Proportion of patients using SABA reliever for symptoms more than two times a week at baseline; 20. Proportion of patients receiving OCS: intermittent (for exacerbations) / regularly (in the frame of basic therapy); 21. Mean number of OCS treatment courses; 22. Median daily dose in case of regular OCS use; 23. Median cumulative OCS exposure for exacerbations 24. Median cumulative OCS exposure in the frame of basic therapy; 25. Mean baseline parameters of lung function (in case of availability of spirometry data)
To describe the baseline eosinophils blood count of outpatients with uncontrolled asthma in the Russian Federation in all patients and in the cohort of patients receiving FDC budesonide/salbutamol on Visit 2
12\. Proportion of patients with different levels of eosinophils blood count (in case of availability of laboratory data): 1. \<150 cells/μl; 2. ≥150 cells/μl; 3. ≥300 cells/μl.
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
according to GINA (Global Initiative for Asthma) score. GINA assessment of asthma control consists of 4 questions, the higher the score the worse asthma control is.
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)
1. Change of reliever; 2. Change of dose of reliever; 3. Change of number of reliever inhalations per day; 4. Change of basic therapy drug; 5. Change of dose of basic therapy drug; 6. Change of number of basic therapy drug inhalations per day; 7. Change of ICS; 8. Dose of ICS increased; 9. Changes of another drug for maintenance therapy. 10. Change in the type of drug delivery within the same INN (e.g. from capsule to powder or from aerosol to powder, etc.)
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)
for patients already used OCS at baseline dose change will be evaluated
4. Proportion of patients with ICS-containing therapy as reliever and as maintenance at visit 2
(in all patients and in the cohort of patients receiving FDC budesonide/salbutamol)
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