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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UNKNOWN
7000 participants
OBSERVATIONAL
2018-03-30
2022-12-31
Brief Summary
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Detailed Description
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The developed RSAR electronic database is a Russian software product that meets the current requirements of the Russian legislation in the field of working with personal data and the implementation of similar observational studies.
Participating researchers also agree to grant access and share anonymous data at the patient level as part of the work to implement the RSAR initiative. Participants will provide high-quality data for the development of data sets for research, approved by the Russian Respiratory Society (RPO), which has priority in owning and implementation in scientific field of the gained data. Based on ethical, legal and regulatory authorizations, anonymous data will be collected in the Central Database (CDB) on respiratory diseases (referred to here as the RSAR database) to create sets of important data and the necessary analysis. CDB is part of the software "Medical online platform ROSMED.INFO".
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients with confirmed diagnosis of severe asthma.
* Patients receiving treatment according to GINA step 5 or uncontrolled for 4 step. Uncontrolled patients are defined as having symptoms of severe asthma or frequent exacerbations .
* Signed informed consent.
Exclusion Criteria
* Intermittent, mild, moderate BA, before verification of the diagnosis.
* COPD.
* Diseases of the respiratory system, such as tuberculosis, sarcoidosis, IPF, lung cancer.
* Vasculitis, systemic connective tissue diseases.
* Neoplasm.
* Written refusal of the patient to participate in the study after signing an informed consent.
12 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Limited Liability Company Regional United System of Medical Informatization
UNKNOWN
Interregional Public Organization, Russian Respiratory Society
OTHER
Responsible Party
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Principal Investigators
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Andrey S Belevskiy, Ph.D.
Role: STUDY_CHAIR
Russian Respiratory Society
Locations
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City hospital 52
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ESR-17-13479
Identifier Type: -
Identifier Source: org_study_id
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