An Ambispective Observational Multicenter Registry of Patients With Uncontrolled Asthma in the Population of the Russian Federation

AstraZeneca48 sites in 1 country9,000 target enrollmentJune 27, 2024

ConditionsUncontrolled Asthma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Uncontrolled Asthma
Sponsor: AstraZeneca
Enrollment: 9000
Locations: 48
Primary Endpoint: To characterise the profile of routine therapy used for outpatients with uncontrolled asthma in the Russian Federation
Status: Recruiting
Last Updated: 12 days ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

June 27, 2024

End Date

September 30, 2026

Last Updated

12 days ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

To characterise the profile of routine therapy used for outpatients with uncontrolled asthma in the Russian Federation

Time Frame: 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

Time Frame: 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