An Ambispective Observational Multicenter Registry of Patients With Uncontrolled Asthma in the Population of the Russian Federation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 9,000
- 试验地点
- 48
- 主要终点
- To characterise the profile of routine therapy used for outpatients with uncontrolled asthma in the Russian Federation
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To characterise the profile of routine therapy used for outpatients with uncontrolled asthma in the Russian Federation
时间窗: 12 weeks (also 52 weeks of retrospective data before visit 1)
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 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
时间窗: 12 weeks (also 52 weeks of retrospective data before visit 1)
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
时间窗: 12 weeks and 52 weeks of retrospective data before visit 1
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
时间窗: 12 weeks (also 52 weeks of retrospective data before visit 1)
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
时间窗: 12 weeks and 52 weeks of retrospective data before visit 1
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.
To describe the baseline mean eosinophils count in sputum 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
时间窗: 12 weeks and 52 weeks of retrospective data before visit 1
13\. Mean eosinophils count in sputum (cells per high power field) (in case of availability of laboratory data);
To describe the baseline mean total IgE 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
时间窗: 12 weeks and 52 weeks of retrospective data before visit 1
14\. Mean total IgE (IU/ml) (in case of availability of laboratory data);
To describe the baseline Proportion of patients with different levels of total IgE 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
时间窗: 12 weeks and 52 weeks of retrospective data before visit 1
15\. Proportion of patients with different levels of total IgE (in case of availability of laboratory data)
To describe the baseline Mean 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
时间窗: 12 weeks and 52 weeks of retrospective data before visit 1
11\. Mean eosinophils blood count (cells/μl) (in case of availability of laboratory data);
次要结局
- 1. Proportion of patients with controlled and partly controlled asthma at visit 2(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(12 weeks (also 52 weeks of retrospective data before visit 1))
- 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(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)(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)(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)(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)(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)(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)(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)(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)(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)(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(12 weeks)
- 12.b 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(12 weeks)
- 12.c 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(12 weeks)
- Proportion of patients with controlled and partlly controlled asthma (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol)(at inclusion into the study, then in 3 months (+-7days) after the inclusion)
- To describe the Proportion of patients with history of smoking/current smokers at visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe mean smoking index for current (tobacco) smokers, according to the assessment at visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe mean duration of smoking (years) for current e-cigarette (vape) smokers in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe change of body mass index (BMI) to visit 3 compared to baseline in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe proportion with overweight (BMI ≥25 kg/m2) in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe Change of body mass index (BMI) to visit 3 compared to baseline in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe proportion of patients with controlled and partly controlled asthma (according to GINA score) at visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe Proportion of patients with controlled and partly controlled asthma (according to the questionnaire ACQ-5) at visit 3 in the cohort of patients receiving FDC budesonide/salbutamol on Visit 2(24 weeks)
- To describe Proportion of patients receiving FDC budesonide/salbutamol as monotherapy or in combination with basic therapy in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe Asthma therapy regimen from which the patient was switched to the FDC budesonide/salbutamol in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe Proportion of patients with changes of inhaled asthma therapy occurred from visit 2 to visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe Proportion of patients with OCS prescription occurred from visit 2 to visit 3; for patients already used OCS at visit 2 dose change will be evaluated in the cohort of patients receiving FDC budesonide/salbutamol on Visit 2(24 weeks)
- To describe Proportion of patients with ICS-containing therapy as reliever and as maintenance at visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe number of budesonide/salbutamol inhalers used between visit 2 and visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe number of budesonide/salbutamol inhalations per month for a period from visit 2 to visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations* between visit 2 and visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe proportion of patients with HRU events occurred between visit 2 and visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe change from Visit 2 Pre- and post-FEV1 at visit 3 (in case of availability of spirometry data) in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe change from Visit 2 Pre- and post-FVC at visit 3 (in case of availability of spirometry data) in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)
- To describe change from Visit Pre-FEF at visit 3 (in case of availability of spirometry data) in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2(24 weeks)