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

Recruiting

• Conditions: Uncontrolled Asthma

• Registration Number: NCT06521229
• Lead Sponsor: AstraZeneca

Brief Summary

This study is a multi-centre, non-interventional, observational, ambispective registry. Planned study population consists of 10 000 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 10 000 patients.

All data will be collected during 2 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 3 months 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.

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.

Study Timeline

• Study First Submitted: 2024-06-21
• Study Start: 2024-06-27
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

1. Age ≥ 18 years at the time of inclusion;
2. Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study;
3. Patients with diagnosis of uncontrolled mild and moderate asthma (according to Global Initiative for Asthma (GINA) score);
4. Patients with the availability of at least 52 weeks of follow-up data (prior to inclusion) in the medical records.

Read More

Exclusion Criteria

1. Patients with severe asthma or/and patients receiving any biological therapy currently or within 52 weeks prior to inclusion;
2. Presence of chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (ILF) currently or in the anamnesis;
3. The participation in any clinical study currently or within 52 weeks prior to inclusion;
4. 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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe the baseline demographic characteristics of outpatients with uncontrolled asthma in the Russian Federation	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; 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.; 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	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);
To characterise the profile of routine therapy used for outpatients with uncontrolled asthma in the Russian Federation	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. 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/regularly; 21. Mean number of OCS treatment courses; 22. Median daily dose in case of regular OCS use; 23. Median cumulative OCS exposure; 24. Mean baseline parameters of lung function (in case of availability of spirometry data)

Secondary Outcome Measures

Name	Time	Method
3. Proportion of patients with OCS prescription occurred from baseline to visit 2	12 weeks (also 52 weeks of retrospective data before visit 1)	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	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	12 weeks (also 52 weeks of retrospective data before visit 1)
12.b Change from baseline in mean parameters of lung function at visit 2 (in case of availability of spirometry data):	12 weeks	b. Pre- and post-FVC (Forced Vital Capacity) (L)
2. Proportion of patients with changes of inhaled asthma therapy occurred from baseline to visit 2:	12 weeks (also 52 weeks of retrospective data before visit 1)	1. Change of reliever; 2. Change of dose of reliever; 3. Change of number of reliever inhalations per day; 4. Change of ICS; 5. Dose of ICS increased; 6. Changes of another drug for maintenance therapy.
Proportion of patients with controlled and partlly controlled asthma	at inclusion into the study, then in 3 months (+-7days) after the inclusion	according to the bronchial asthma symptom control questionnaire (ACQ-5). Uncontrolled asthma is defined as \>1.5 points according to the Asthma Symptom Control Questionnaire (ACQ-5). The higher the score, the worse
12.c Change from baseline in mean parameters of lung function at visit 2 (in case of availability of spirometry data):	12 weeks	c. Pre-FEF (Forced Expiratory Flow). Measured in L/sec.
1. Proportion of patients with controlled and partly controlled asthma at visit 2	12 weeks (also 52 weeks of retrospective data before visit 1)	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.
7. Annualised rate of severe asthma exacerbations*	during 52 weeks prior to inclusion
8. Cumulative days of severe asthma exacerbations*	during 52 weeks prior to inclusion
9. Proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations*	12 weeks
10. Proportion of patients with healthcare resource utilization (HRU) events	during 52 weeks prior to inclusion	1. Unscheduled outpatient visits; 2. Emergency department visits/emergency calls; 3. Hospitalizations
11. Proportion of patients with HRU events	12 weeks	d. Unscheduled outpatient visits; e. Emergency department visits/emergency calls; f. Hospitalizations.
6. Proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations	during 52 weeks prior to inclusion	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.
12.a Change from baseline in mean parameters of lung function at visit 2 (in case of availability of spirometry data):	12 weeks	a. Pre- and post-FEV1 (Forced Expiratory Volume in 1 second). % predicted and L

Trial Locations

Locations (1)

Research Site; 🇷🇺 Yuzhno-Sakhalinsk, Russian Federation