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

Launched by ASTRAZENECA · Jul 24, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding the characteristics of adult patients in Russia who have uncontrolled asthma. Uncontrolled asthma means that a person's asthma symptoms are not well managed, even though they are receiving treatment. The study aims to gather information from about 10,000 patients across 70 outpatient centers throughout Russia. The goal is to learn more about these patients, including their demographics and how their asthma affects them in different regions of the country.

To be eligible for this study, participants must be at least 18 years old, have a diagnosis of mild to moderate uncontrolled asthma, and have at least a year of medical records available for review. It's important to note that patients with severe asthma or those currently receiving certain advanced treatments (like biological therapy) cannot participate. Those who join the study will help researchers better understand uncontrolled asthma and may contribute to improving treatment options in the future. Participants will not receive any experimental treatments but will continue with their regular asthma care.

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Eligibility criteria

• 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.