Clinical trial NCT03608566: Russian Severe Asthma Registry
Official title: The Russian Registry of Patients With Severe Asthma to Collect Anonymous Long-term Evidence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Asthma
Keywords: severe asthma
Lead sponsor: Interregional Public Organization, Russian Respiratory Society
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Limited Liability Company Regional United System of Medical Informatization
First posted: 2018-08-01
Enrollment: 7000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving step 4 and 5 treatment (according to GINA, 2017) in accordance with the uncontrolled asthma severity (J.45) in health facilities

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

Detailed 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".

Eligibility criteria: 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.

Primary outcomes:
measure: • Percentage of patients with severe asthma according frequency of exacerbations at the time of study enrollment
timeFrame: 03.2018 till 11.2022.
Secondary outcomes:
measure: • Percentage of patients with severe asthma according frequency of exacerbations at the 1 year of follow-up;
timeFrame: 03.2019 till 11.2022.
measure: Percentage of patients with severe asthma according frequency of exacerbations at the 2 year of follow-up;
timeFrame: 03.2020 till 11.2022.
measure: • Percentage of patients with severe asthma according frequency of exacerbations at the 3 year of follow-up;
timeFrame: 03.2021 till 11.2022.
measure: • Percentage of patients with severe asthma according frequency of exacerbations (1, 2, ≥3 exacerbations) at the 4 year of follow-up;
timeFrame: 03.2022 till 11.2022.
measure: • Percentage of patients with severe asthma according concomitant diseases at the time of study enrollment
timeFrame: 03.2018 till 11.2022.
measure: • Percentage of patients with severe asthma according concomitant diseases at the 1year of follow-up;
timeFrame: 03.2019 till 11.2022.
measure: • Percentage of patients with severe asthma according concomitant diseases at the 2 year of follow-up;
timeFrame: 03.2020 till 11.2022
measure: • Percentage of patients with severe asthma according concomitant diseases at the 3 year of follow-up;
timeFrame: 03.2021 till 11.2022
measure: • Percentage of patients with severe asthma according concomitant diseases at the 4 year of follow-up;
timeFrame: 03.2022 till 11.2022
measure: • • Percentage of patients with severe asthma according to parameters: age at the time of study enrollment;
timeFrame: 03.2018 till 11.2022
measure: • • Percentage of patients with severe asthma according to parameters: sex at the time of study enrollment;
timeFrame: 03.2018 till 11.2022
measure: • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) at the time of enrollment
timeFrame: 03.2018 till 11.2022
measure: • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) at the 1year of follow-up;
timeFrame: 03.2019 till 11.2022
measure: • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) at the 2year of follow-up;
timeFrame: 03.2020 till 11.2022
measure: • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) at the 3 year of follow-up;
timeFrame: 03.2021 till 11.2022
measure: • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) at the 4 year of follow-up;
timeFrame: 03.2022 till 11.2022
measure: • Percentage of patients with severe asthma with different phenotypes in terms of eosinophil levels in absolute values in complete blood count at the time of enrollment;
timeFrame: 03.2018 till 11.2022
measure: • Percentage of patients with severe asthma with different phenotypes in terms of eosinophil levels in absolute values in complete blood count at the 1 year of follow-up;
timeFrame: 03.2019 till 11.2022
measure: • Percentage of patients with severe asthma with different phenotypes in terms of eosinophil levels in absolute values in complete blood count at the 2 year of follow-up;
timeFrame: 03.2020 till 11.2022
measure: • Percentage of patients with severe asthma with different phenotypes in terms of eosinophil levels in absolute values in complete blood count at the 3 year of follow-up;
timeFrame: 03.2021 till 11.2022
measure: • Percentage of patients with severe asthma with different phenotypes in terms of eosinophil levels in absolute values in complete blood count at the 4 year of follow-up;
timeFrame: 03.2022 till 11.2022
measure: • The parameters of body mass index in the patients with severe asthma at the time of study enrollment;
timeFrame: 03.2018 till 11.2022
measure: • Percentage of patients with severe asthma in the parameters: of smoking at the time of study enrollment;
timeFrame: 03.2018 till 11.2022
measure: • Percentage of patients with severe asthma in the parameters: of professional history at the time of study enrollment;
timeFrame: 03.2018 till 11.2022
measure: • Percentage of patients with severe asthma in the parameters: of family history at the time of study enrollment;
timeFrame: 03.2018 till 11.2022
measure: • Parameters of FEV1 (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the time of study enrollment;
timeFrame: 03.2018 till 11.2022
measure: • Parameters of FVC (liters, percentage of predicted)before bronchodilator in patients with severe asthma at the time of study enrollment
timeFrame: 03.2018 till 11.2022
measure: • Parameters of FEV1 (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the time of study enrollment;
timeFrame: 03.2018 till 11.2022
measure: • Parameters of FVC (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the time of study enrollment;
timeFrame: 03.2018 till 11.2022
measure: • Parameters of FEV1 (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 1 year of follow-up
timeFrame: 03.2019 till 11.2022
measure: • Parameters of FVC (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 1year of follow-up;
timeFrame: 03.2019 till 11.2022
measure: • Parameters of FEV1 (liters, percentage of predicted) (the mean value, the standard deviation) post bronchodilator in patients with severe asthma at the 1 year of follow-up;
timeFrame: 03.2019 till 11.2022
measure: • Parameters of FVC (liters, percentage of predicted) (the mean value, the standard deviation) post bronchodilator in patients with severe asthma at the 1year of follow-up;
timeFrame: 03.2019 till 11.2022
measure: • Parameters of FEV1 (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 2 year of follow-up;
timeFrame: 03.2020 till 11.2022
measure: • Parameters of FVC (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 2year of follow-up;
timeFrame: 03.2020 till 11.2022
measure: • Parameters of FEV1 (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 2 year of follow-up;
timeFrame: 03.2020 till 11.2022
measure: • Parameters of FVC (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 2year of follow-up;
timeFrame: 03.2020 till 11.2022
measure: • Parameters of FEV1 (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 3 year of follow-up
timeFrame: 03.2021 till 11.2022
measure: • Parameters of FVC (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 3year of follow-up
timeFrame: 03.2021 till 11.2022
measure: • Parameters of FEV1 (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 3 year of follow-up
timeFrame: 03.2021 till 11.2022
measure: • Parameters of FVC (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 3year of follow-up
timeFrame: 03.2021 till 11.2022
measure: • Parameters of FEV1 (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 4 year of follow-up
timeFrame: 03.2022 till 11.2022
measure: • Parameters of FVC (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 4 year of follow-up
timeFrame: 03.2022 till 11.2022
measure: • Parameters of FEV1 (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 4 year of follow-up;
timeFrame: 03.2022 till 11.2022
measure: • Parameters of FVC (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 4 year of follow-up;
timeFrame: 03.2022 till 11.2022
measure: • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the time of study enrollment;
timeFrame: 03.2018 till 11.2022
measure: • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 1 year of follow-up;
timeFrame: 03.2019 till 11.2022
measure: • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 2 year of follow-up;
timeFrame: 03.2020 till 11.2022
measure: • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 3 year of follow-up;
timeFrame: 03.2021 till 11.2022
measure: • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 4 year of follow-up;
timeFrame: 03.2022 till 11.2022
measure: • Number of exacerbations requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the time of study enrollment;
timeFrame: 03.2018 till 11.2022
measure: • Number of exacerbations requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 1year of follow-up;
timeFrame: 03.2019 till 11.2022
measure: • Number of exacerbations requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 2year of follow-up;
timeFrame: 03.2020 till 11.2022
measure: • Number of exacerbations requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 3 year of follow-up;
timeFrame: 03.2021 till 11.2022
measure: • Number of exacerbations requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 4 year of follow-up;
timeFrame: 03.2022 till 11.2022
measure: • Number of hospitalizations in patients with severe asthma at the time of inclusion in the study;
timeFrame: 03.2018 till 11.2022
measure: • Number of hospitalizations in patients with severe asthma at the time of inclusion in the 1 year of follow-up;
timeFrame: 03.2019 till 11.2022
measure: • Number of hospitalizations in patients with severe asthma at the time of inclusion in the 2 year of follow-up;
timeFrame: 03.2020 till 11.2022
measure: • Number of hospitalizations in patients with severe asthma at the time of inclusion in the 3 year of follow-up;
timeFrame: 03.2021 till 11.2022
measure: • Number of hospitalizations in patients with severe asthma at the time of inclusion in the 4 year of follow-up;
timeFrame: 03.2022 till 11.2022
measure: • Percentage of patients with severe asthma taking high doses of ICS/LABA, ICS/LABA+LAMA as maintenance therapy, biologics at the time of study enrollment;
timeFrame: 03.2018 till 11.2022
measure: • Percentage of patients with severe asthma taking high doses of ICS/LABA, ICS/LABA+LAMA as maintenance therapy, biologics at the 1 year of follow-up;
timeFrame: 03.2019 till 11.2022
measure: • Percentage of patients with severe asthma taking high doses of ICS/LABA, ICS/LABA+LAMA as maintenance therapy, biologics at the 2 year of follow-up;
timeFrame: 03.2020 till 11.2022
measure: • Percentage of patients with severe asthma taking high doses of ICS/LABA, ICS/LABA+LAMA as maintenance therapy, biologics at the 3 year of follow-up;
timeFrame: 03.2021 till 11.2022
measure: • Percentage of patients with severe asthma taking high doses of ICS/LABA, ICS/LABA+LAMA as maintenance therapy, biologics at the 4 year of follow-up;
timeFrame: 03.2022 till 11.2022
measure: • Percentage of patients with severe asthma taking OCS as a maintenance therapy at the time of study enrollment;
timeFrame: 03.2018 till 11.2022
measure: • Percentage of patients with severe asthma taking OCS as a maintenance therapy at the 1 year of follow-up;
timeFrame: 03.2019 till 11.2022
measure: • Percentage of patients with severe asthma taking OCS as a maintenance therapy at the 2 year of follow-up;
timeFrame: 03.2020 till 11.2022
measure: • Percentage of patients with severe asthma taking OCS as a maintenance therapy at the 3 year of follow-up;
timeFrame: 03.2021 till 11.2022
measure: • Percentage of patients with severe asthma taking OCS as a maintenance therapy at the 4 year of follow-up;
timeFrame: 03.2022 till 11.2022
measure: • Percentage of patients with severe asthma who have been changed therapy to 1 year of follow-up;
timeFrame: 03.2019 till 11.2022
measure: • Percentage of patients with severe asthma who have been changed therapy to 2 year of follow-up;
timeFrame: 03.2020 till 11.2022
measure: • Percentage of patients with severe asthma who have been changed therapy to 3 year of follow-up;
timeFrame: 03.2021 till 11.2022
measure: • Percentage of patients with severe asthma who have been changed therapy to 4 year of follow-up;
timeFrame: 03.2022 till 11.2022
measure: • Percentage of patients with severe asthma who called for emergency medical care for asthma at the 1 year of follow-up;
timeFrame: 03.2019 till 11.2022
measure: • Percentage of patients with severe asthma who called for emergency medical care for asthma at the 2 year of follow-up;
timeFrame: 03.2020 till 11.2022
measure: • Percentage of patients with severe asthma who called for emergency medical care for asthma at the 3 year of follow-up;
timeFrame: 03.2021 till 11.2022
measure: • Percentage of patients with severe asthma who called for emergency medical care for asthma at the 4 year of follow-up;
timeFrame: 03.2022 till 11.2022
measure: • Percentage of patients with severe asthma who had disability sheets for asthma at the 1year of follow-up;
timeFrame: 03.2019 till 11.2022
measure: • Percentage of patients with severe asthma who had disability sheets for asthma at the 2 year of follow-up;
timeFrame: 03.2020 till 11.2022
measure: • Percentage of patients with severe asthma who had disability sheets for asthma at the 3 year of follow-up;
timeFrame: 03.2021 till 11.2022
measure: • Percentage of patients with severe asthma who had disability sheets for asthma at the 4 year of follow-up;
timeFrame: 03.2022 till 11.2022
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: City hospital 52
Study officials:
affiliation: Russian Respiratory Society
name: Andrey S Belevskiy, Ph.D.
role: STUDY_CHAIR
References: