Russian Severe Asthma Registry (RSAR)

Interregional Public Organization, Russian Respiratory Society

Status: Unknown

Conditions: Severe Asthma

Study type: Observational

Funder types: Other

Identifiers

NCT03608566

ESR-17-13479

Details and patient eligibility

About

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

Full description

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".

Enrollment: 7,000 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design