Clinical& Demographic Profiles of patIents With unControllEd Asthma in Russia: Multi-center oBsErvational ReGistry Study
NCT ID: NCT06521229
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2024-06-27
2026-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
OTHER
Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Astrakhan, , Russia
Research Site
Blagoveshchensk, , Russia
Research Site
Bryansk, , Russia
Research Site
Chelyabinsk, , Russia
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Gatchina, , Russia
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Irkutsk, , Russia
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Ivanovo, , Russia
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Izhevsk, , Russia
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Kazan', , Russia
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Kemerovo, , Russia
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Krasnodar, , Russia
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Krasnoyarsk, , Russia
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Lipetsk, , Russia
Research Site
Makhachkala, , Russia
Research Site
Moscow, , Russia
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Murmansk, , Russia
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Nal'chik, , Russia
Research Site
Nizhny Novgorod, , Russia
Research Site
Nizhny Tagil, , Russia
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Novokuznetsk, , Russia
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Novosibirsk, , Russia
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Omsk, , Russia
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Orenburg, , Russia
Research Site
Perm, , Russia
Research Site
Petrozavodsk, , Russia
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Pyatigorsk, , Russia
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Rostov-on-Don, , Russia
Research Site
Ryazan, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Samara, , Russia
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Saratov, , Russia
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Smolensk, , Russia
Research Site
Stavropol, , Russia
Research Site
Surgut, , Russia
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Tomsk, , Russia
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Tula, , Russia
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Ufa, , Russia
Research Site
Ulan-Ude, , Russia
Research Site
Verkhnyaya Pyshma, , Russia
Research Site
Vladimir, , Russia
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Vladivostok, , Russia
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Voronezh, , Russia
Research Site
Yaroslavl, , Russia
Research Site
Yekaterinburg, , Russia
Research Site
Yuzhno-Sakhalinsk, , Russia
Countries
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Central Contacts
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Other Identifiers
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D2287R00206
Identifier Type: -
Identifier Source: org_study_id
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