Observational study of patients with uncontrolled severe asthma in Russia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Astrakhan, Russia Recruiting
• Research Site
  Barnaul, Russia Recruiting
• Research Site
  Blagoveshchensk, Russia Recruiting
• Research Site
  Bryansk, Russia Recruiting
• Research Site
  Chelyabinsk, Russia Recruiting
• Research Site
  Gatchina, Russia Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Structured physical activity program added to tezepelumab for adults with severe asthma

  A 12-week program to help adults with severe asthma who start tezepelumab see if adding guided physical activity improves activity levels and chances of remission.

  Recruiting University of Leeds · Leeds · NCT07735494

• Exercise program for adults with severe asthma starting biologics

  A tailored exercise program is being tested to see if it helps adults with severe asthma who are starting biologic therapy feel better and breathe better.

  Recruiting Helsinki University Central Hospital · Helsinki · NCT07655037

• Frevecitinib (KN-002) for severe asthma: a 12-week dose-ranging study

  This study tests three doses of frevecitinib vs placebo to see if it helps people with severe asthma not controlled by standard inhaled steroids and LABA therapy.

  Recruiting at 9 sites Phase 2 Kinaset Therapeutics Inc · Lancaster, California and 13 other locations · NCT07532265

• Benralizumab treatment for adults with ABPA and severe asthma

  This will test whether benralizumab helps adults (18–75) who have severe asthma with allergic bronchopulmonary aspergillosis (ABPA).

  Recruiting at 2 sites Qianfoshan Hospital · Jinan, Shandong and 1 other locations · NCT07530770

• Tezepelumab to reduce maintenance medication in people with severe asthma

  This will test whether people aged 12–80 with severe asthma in China who start tezepelumab can safely reduce their regular maintenance medicines while keeping asthma controlled.

  Recruiting at 59 sites Phase 3 AstraZeneca · Beijing and 74 other locations · NCT07363642

• GB-0895 as an add-on treatment for severe uncontrolled asthma in adolescents and adults

  This test tries to see if adding GB-0895 every six months helps adolescents and adults whose severe asthma isn't controlled by inhaled steroids and other controllers.

  Recruiting at 158 sites Phase 3 Generate Biomedicines · Bakersfield, California and 157 other locations · NCT07359846

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.