Russian Severe Asthma Registry

NCT ID: NCT03608566

Last Updated: 2018-08-10

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

7000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-30

Study Completion Date

2022-12-31

Brief Summary

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The Russian Severe Asthma Registry is a Russian initiative to collect anonymous long-term evidence for patients with severe asthma in Russia

Detailed Description

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The Russian Severe Asthma Registry is a Russian initiative to collect anonymous long-term evidence for patients with severe asthma in Russia. The RSAR initiative is realized under the efforts of the Interregional Public Organization "Russian Respiratory Society" and LLC "RSMI" with the sponsorship of "AstraZeneca Pharmaceuticals" LLC.

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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Severe Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients aged 12 years or older.

* 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

* Patients currently participating in clinical trials at the time of enrolment

* 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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Limited Liability Company Regional United System of Medical Informatization

UNKNOWN

Sponsor Role collaborator

Interregional Public Organization, Russian Respiratory Society

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Andrey S Belevskiy, Ph.D.

Role: CONTACT

+79852336400

Natalia M Nenasheva, Ph.D.

Role: CONTACT

+79037236927

Facility Contacts

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Natalia M Nenasheva, PhD

Role: primary

+79037236927

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ESR-17-13479

Identifier Type: -

Identifier Source: org_study_id

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