Recruiting

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

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).

ClinicalTrials.gov IDNCT06521229

PhaseNot Applicable

Enrollment9000

SponsorAstraZeneca

AgeNo minimum reported

SexALL

I'm interested View official listing

Conditions studied

Uncontrolled Asthma

About this study

Primary outcomes

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 (12 weeks (also 52 weeks of retrospective data before visit 1))
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 (12 weeks and 52 weeks of retrospective data before visit 1)
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 (12 weeks (also 52 weeks of retrospective data before visit 1))
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 weeks and 52 weeks of retrospective data before visit 1)
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 (12 weeks and 52 weeks of retrospective data before visit 1)
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 (12 weeks and 52 weeks of retrospective data before visit 1)
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 (12 weeks and 52 weeks of retrospective data before visit 1)
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 (12 weeks and 52 weeks of retrospective data before visit 1)

Eligibility information

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. 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.

Study locations

Research Site, Astrakhan, Russia
Research Site, Blagoveshchensk, Russia
Research Site, Bryansk, Russia
Research Site, Chelyabinsk, Russia
Research Site, Gatchina, Russia
Research Site, Irkutsk, Russia
Research Site, Ivanovo, Russia
Research Site, Izhevsk, Russia
Research Site, Kazan', Russia
Research Site, Kemerovo, Russia

Showing 10 of 47 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.