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Observational study of patients with uncontrolled severe asthma in Russia

An Observational Multicenter Cross-sectional Study of Patients With Uncontrolled Severe Asthma in the Population of the Russian Federation

Observational AstraZeneca · NCT06472310

This study looks at 5,000 adults in Russia with severe asthma to learn more about their treatment and health outcomes while they continue their usual care.

Quick facts

Study typeObservational
Enrollment5000 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Locations37 sites (Astrakhan and 36 other locations)
Trial IDNCT06472310 on ClinicalTrials.gov

What this trial studies

This observational multicenter cross-sectional study aims to enroll 5,000 adult patients with uncontrolled severe asthma receiving standard care treatment across 50 outpatient centers in Russia. The study seeks to gather comprehensive epidemiological and clinical data on patients with severe asthma, focusing on their characteristics, treatment approaches, and outcomes. By analyzing data from various regions, the study aims to fill the gaps in understanding the disease's impact and management in the Russian population. No interventions will be made, as the study will rely on routine clinical practices.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of uncontrolled severe asthma and at least 52 weeks of follow-up data.

Not a fit: Patients currently receiving biological therapy will not benefit from this study as they are excluded from participation.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the characteristics and treatment of uncontrolled severe asthma, potentially leading to improved management strategies for patients.

How similar studies have performed: Previous observational registries have been conducted, but this study is unique in its focus on patients not receiving biological treatments in the Russian context.

Eligibility criteria

Show full inclusion / exclusion 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 SA (Asthma Control Questionnaire-5 (ACQ-5) score \> 1,5) established no less than 52 weeks prior to inclusion; Severe asthma is defined as asthma, that is controlled due to treatment with ICS in medium or high doses plus LABA and/or ALP, and/or LAMA, and/or systemic corticosteroids (sCS), and/or immunobiological therapy, while attempts to reduce the volume of therapy lead to a loss of symptom control, or asthma remains uncontrolled despite this treatment. Such therapy should be carried out at least 3 months before inclusion.

   Uncontrolled asthma is defined as ACQ-5\>1.5.
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 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.

Where this trial is running

Astrakhan and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Severe Asthmauncontrolled severe asthmaSA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.