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

Last updated: March 19, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asthma

Treatment

N/A

Clinical Study ID

NCT06521229
D2287R00206
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 lawprior to inclusion in the study;

  3. Patients with diagnosis of uncontrolled mild and moderate asthma (according toGlobal Initiative for Asthma (GINA) score);

  4. Patients with the availability of at least 52 weeks of follow-up data (prior toinclusion) in the medical records.

Exclusion

Exclusion Criteria:

  1. Patients with severe asthma or/and patients receiving any biological therapycurrently or within 52 weeks prior to inclusion;

  2. Presence of chronic obstructive pulmonary disease (COPD) or idiopathic pulmonaryfibrosis (ILF) currently or in the anamnesis;

  3. The participation in any clinical study currently or within 52 weeks prior toinclusion;

  4. An acute or chronic disease that, as deemed by Investigator, limits the ability ofpatients to participate in this study or could influence the interpretation of theresults.

Study Design

Total Participants: 10000
Study Start date:
June 27, 2024
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • Research Site

    Astrakhan,
    Russian Federation

    Active - Recruiting

  • Research Site

    Blagoveshchensk,
    Russian Federation

    Site Not Available

  • Research Site

    Bryansk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Chelyabinsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Gatchina,
    Russian Federation

    Active - Recruiting

  • Research Site

    Irkutsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Ivanovo,
    Russian Federation

    Active - Recruiting

  • Research Site

    Izhevsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Kazan,
    Russian Federation

    Active - Recruiting

  • Research Site

    Kemerovo,
    Russian Federation

    Active - Recruiting

  • Research Site

    Krasnodar,
    Russian Federation

    Active - Recruiting

  • Research Site

    Krasnoyarsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Moscow,
    Russian Federation

    Active - Recruiting

  • Research Site

    Murmansk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Nalchik,
    Russian Federation

    Active - Recruiting

  • Research Site

    Nizhny Novgorod,
    Russian Federation

    Active - Recruiting

  • Research Site

    Nizhny Tagil,
    Russian Federation

    Site Not Available

  • Research Site

    Novokuznetsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Novosibirsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Omsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Orenburg,
    Russian Federation

    Active - Recruiting

  • Research Site

    Pyatigorsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Rostov on Don,
    Russian Federation

    Site Not Available

  • Research Site

    Rostov-on-Don,
    Russian Federation

    Active - Recruiting

  • Research Site

    Ryazan,
    Russian Federation

    Active - Recruiting

  • Research Site

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Research Site

    Saint-Petersburg,
    Russian Federation

    Active - Recruiting

  • Research Site

    Samara,
    Russian Federation

    Active - Recruiting

  • Research Site

    Saratov,
    Russian Federation

    Active - Recruiting

  • Research Site

    Smolensk,
    Russian Federation

    Site Not Available

  • Research Site

    Stavropol,
    Russian Federation

    Active - Recruiting

  • Research Site

    Surgut,
    Russian Federation

    Active - Recruiting

  • Research Site

    Tomsk,
    Russian Federation

    Active - Recruiting

  • Research Site

    Tula,
    Russian Federation

    Active - Recruiting

  • Research Site

    Ufa,
    Russian Federation

    Active - Recruiting

  • Research Site

    Ulan Ude,
    Russian Federation

    Site Not Available

  • Research Site

    Ulan-Ude,
    Russian Federation

    Active - Recruiting

  • Research Site

    Verkhnyaya Pyshma,
    Russian Federation

    Active - Recruiting

  • Research Site

    Vladimir,
    Russian Federation

    Active - Recruiting

  • Research Site

    Vladivostok,
    Russian Federation

    Active - Recruiting

  • Research Site

    Voronezh,
    Russian Federation

    Active - Recruiting

  • Research Site

    Yaroslavl,
    Russian Federation

    Active - Recruiting

  • Research Site

    Yekaterinburg,
    Russian Federation

    Active - Recruiting

  • Research Site

    Yuzhno-Sakhalinsk,
    Russian Federation

    Active - Recruiting

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