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Russian Severe Asthma Registry (RSAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03608566
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : August 10, 2018
Sponsor:
Collaborators:
AstraZeneca Pharmaceuticals" LLC
Limited Liability Company Regional United System of Medical Informatization
Information provided by (Responsible Party):
Interregional Public Organization, Russian Respiratory Society

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

Condition or disease
Severe Asthma

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".

Study Design
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Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 7000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The Russian Registry of Patients With Severe Asthma to Collect Anonymous Long-term Evidence
Actual Study Start Date : March 30, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. • Percentage of patients with severe asthma according frequency of exacerbations at the time of study enrollment [ Time Frame: 03.2018 till 11.2022. ]
    Percentage of patients with severe asthma according frequency of exacerbations (1, 2, ≥3 exacerbations) at the time of study enrollment


Secondary Outcome Measures :
  1. • Percentage of patients with severe asthma according frequency of exacerbations at the 1 year of follow-up; [ Time Frame: 03.2019 till 11.2022. ]
    • Percentage of patients with severe asthma according frequency of exacerbations (1, 2, ≥3 exacerbations) at the 1 year of follow-up;

  2. Percentage of patients with severe asthma according frequency of exacerbations at the 2 year of follow-up; [ Time Frame: 03.2020 till 11.2022. ]
    • Percentage of patients with severe asthma according frequency of exacerbations (1, 2, ≥3 exacerbations) at the 2 year of follow-up;

  3. • Percentage of patients with severe asthma according frequency of exacerbations at the 3 year of follow-up; [ Time Frame: 03.2021 till 11.2022. ]
    • • Percentage of patients with severe asthma according frequency of exacerbations (1, 2, ≥3 exacerbations) at the 3 year of follow-up;

  4. • Percentage of patients with severe asthma according frequency of exacerbations (1, 2, ≥3 exacerbations) at the 4 year of follow-up; [ Time Frame: 03.2022 till 11.2022. ]
    • Percentage of patients with severe asthma according frequency of exacerbations (1, 2, ≥3 exacerbations) at the 4 year of follow-up;

  5. • Percentage of patients with severe asthma according concomitant diseases at the time of study enrollment [ Time Frame: 03.2018 till 11.2022. ]
    • Percentage of patients with severe asthma according concomitant diseases (number of observations, the mean value, the standard deviation) at the time of study enrollment

  6. • Percentage of patients with severe asthma according concomitant diseases at the 1year of follow-up; [ Time Frame: 03.2019 till 11.2022. ]
    • Percentage of patients with severe asthma according concomitant diseases (number of observations, the mean value, the standard deviation) at the 1year of follow-up;

  7. • Percentage of patients with severe asthma according concomitant diseases at the 2 year of follow-up; [ Time Frame: 03.2020 till 11.2022 ]
    • Percentage of patients with severe asthma according concomitant diseases (number of observations, the mean value, the standard deviation) at the 2 year of follow-up;

  8. • Percentage of patients with severe asthma according concomitant diseases at the 3 year of follow-up; [ Time Frame: 03.2021 till 11.2022 ]
    • Percentage of patients with severe asthma according concomitant diseases (number of observations, the mean value, the standard deviation) at the 3 year of follow-up;

  9. • Percentage of patients with severe asthma according concomitant diseases at the 4 year of follow-up; [ Time Frame: 03.2022 till 11.2022 ]
    • Percentage of patients with severe asthma according concomitant diseases (number of observations, the mean value, the standard deviation) at the 3 year of follow-up;

  10. • • Percentage of patients with severe asthma according to parameters: age at the time of study enrollment; [ Time Frame: 03.2018 till 11.2022 ]
    • • Percentage of patients with severe asthma according to parameters: age (the mean value, the standard deviation) at the time of study enrollment;

  11. • • Percentage of patients with severe asthma according to parameters: sex at the time of study enrollment; [ Time Frame: 03.2018 till 11.2022 ]
    • • Percentage of patients with severe asthma according to parameters: sex at the time of study enrollment;

  12. • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) at the time of enrollment [ Time Frame: 03.2018 till 11.2022 ]
    • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) (the mean value, the standard deviation, the minimum value, median, maximum value) at the time of enrollment

  13. • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) at the 1year of follow-up; [ Time Frame: 03.2019 till 11.2022 ]
    • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) (the mean value, the standard deviation, the minimum value, median, maximum value) at the 1year of follow-up;

  14. • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) at the 2year of follow-up; [ Time Frame: 03.2020 till 11.2022 ]
    • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) (the mean value, the standard deviation, the minimum value, median, maximum value) at the 2year of follow-up;

  15. • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) at the 3 year of follow-up; [ Time Frame: 03.2021 till 11.2022 ]
    • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) (the mean value, the standard deviation, the minimum value, median, maximum value) at the 3year of follow-up;

  16. • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) at the 4 year of follow-up; [ Time Frame: 03.2022 till 11.2022 ]
    • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) (the mean value, the standard deviation, the minimum value, median, maximum value) at the 4 year of follow-up;

  17. • 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; [ Time Frame: 03.2018 till 11.2022 ]
    • Percentage of patients with severe asthma with different phenotypes in terms of eosinophil levels in absolute values in complete blood count (number of observations, the mean value, the standard deviation, the minimum value, median, maximum value) at the time of enrollment;

  18. • 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; [ Time Frame: 03.2019 till 11.2022 ]
    • Percentage of patients with severe asthma with different phenotypes in terms of eosinophil levels in absolute values in complete blood count (number of observations, the mean value, the standard deviation, the minimum value, median, maximum value) at the 1 year of follow-up;

  19. • 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; [ Time Frame: 03.2020 till 11.2022 ]
    • Percentage of patients with severe asthma with different phenotypes in terms of eosinophil levels in absolute values in complete blood count (number of observations, the mean value, the standard deviation, the minimum value, median, maximum value) at the 2 year of follow-up;

  20. • 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; [ Time Frame: 03.2021 till 11.2022 ]
    • Percentage of patients with severe asthma with different phenotypes in terms of eosinophil levels in absolute values in complete blood count (number of observations, the mean value, the standard deviation, the minimum value, median, maximum value) at the 3 year of follow-up;

  21. • 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; [ Time Frame: 03.2022 till 11.2022 ]
    • Percentage of patients with severe asthma with different phenotypes in terms of eosinophil levels in absolute values in complete blood count (number of observations, the mean value, the standard deviation, the minimum value, median, maximum value) at the 4 year of follow-up;

  22. • The parameters of body mass index in the patients with severe asthma at the time of study enrollment; [ Time Frame: 03.2018 till 11.2022 ]
    • The parameters of body mass index (kg/m2) in the patients with severe asthma at the time of study enrollment the mean value, the standard deviation, the minimum value, median, maximum value)

  23. • Percentage of patients with severe asthma in the parameters: of smoking at the time of study enrollment; [ Time Frame: 03.2018 till 11.2022 ]
    • Percentage of patients with severe asthma in the parameters: of smoking (smoker's index (pack-years)) at the time of study enrollment;

  24. • Percentage of patients with severe asthma in the parameters: of professional history at the time of study enrollment; [ Time Frame: 03.2018 till 11.2022 ]
    • Percentage of patients with severe asthma in the parameters: of professional history (having or not occupational hazards at any time of life) at the time of study enrollment;

  25. • Percentage of patients with severe asthma in the parameters: of family history at the time of study enrollment; [ Time Frame: 03.2018 till 11.2022 ]
    • Percentage of patients with severe asthma in the parameters: of family history at the time of study enrollment; having or not first degree relatives with asthma

  26. • Parameters of FEV1 (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the time of study enrollment; [ Time Frame: 03.2018 till 11.2022 ]
    • Parameters of FEV1 (liters, percentage of predicted) (the mean value, the standard deviation) before bronchodilator in patients with severe asthma at the time of study enrollment;

  27. • Parameters of FVC (liters, percentage of predicted)before bronchodilator in patients with severe asthma at the time of study enrollment [ Time Frame: 03.2018 till 11.2022 ]
    • Parameters of FVC (liters, percentage of predicted) (the mean value, the standard deviation) before bronchodilator in patients with severe asthma at the time of study enrollment

  28. • Parameters of FEV1 (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the time of study enrollment; [ Time Frame: 03.2018 till 11.2022 ]
    • Parameters of FEV1 (liters, percentage of predicted) (the mean value, the standard deviation) post bronchodilator in patients with severe asthma at the time of study enrollment;

  29. • Parameters of FVC (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the time of study enrollment; [ Time Frame: 03.2018 till 11.2022 ]
    • Parameters of FVC (liters, percentage of predicted) (the mean value, the standard deviation) post bronchodilator in patients with severe asthma at the time of study enrollment;

  30. • Parameters of FEV1 (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 1 year of follow-up [ Time Frame: 03.2019 till 11.2022 ]
    • Parameters of FEV1 (liters, percentage of predicted) (the mean value, the standard deviation) before bronchodilator in patients with severe asthma at the 1 year of follow-up

  31. • Parameters of FVC (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 1year of follow-up; [ Time Frame: 03.2019 till 11.2022 ]
    • Parameters of FVC (liters, percentage of predicted) (the mean value, the standard deviation) before bronchodilator in patients with severe asthma at the 1year of follow-up;

  32. • 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; [ Time Frame: 03.2019 till 11.2022 ]
    • Parameters of FEV1 (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 1 year of follow-up;

  33. • 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; [ Time Frame: 03.2019 till 11.2022 ]
    • Parameters of FVC (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 1year of follow-up;

  34. • Parameters of FEV1 (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 2 year of follow-up; [ Time Frame: 03.2020 till 11.2022 ]
    • Parameters of FEV1 (liters, percentage of predicted) (the mean value, the standard deviation) before bronchodilator in patients with severe asthma at the 2 year of follow-up;

  35. • Parameters of FVC (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 2year of follow-up; [ Time Frame: 03.2020 till 11.2022 ]
    • Parameters of FVC (liters, percentage of predicted) (the mean value, the standard deviation) before bronchodilator in patients with severe asthma at the 2year of follow-up;

  36. • Parameters of FEV1 (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 2 year of follow-up; [ Time Frame: 03.2020 till 11.2022 ]
    • Parameters of FEV1 (liters, percentage of predicted) (the mean value, the standard deviation) post bronchodilator in patients with severe asthma at the 2 year of follow-up;

  37. • Parameters of FVC (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 2year of follow-up; [ Time Frame: 03.2020 till 11.2022 ]
    • Parameters of FVC (liters, percentage of predicted) (the mean value, the standard deviation) post bronchodilator in patients with severe asthma at the 2year of follow-up;

  38. • Parameters of FEV1 (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 3 year of follow-up [ Time Frame: 03.2021 till 11.2022 ]
    • Parameters of FEV1 (liters, percentage of predicted) (the mean value, the standard deviation) before bronchodilator in patients with severe asthma at the 3 year of follow-up

  39. • Parameters of FVC (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 3year of follow-up [ Time Frame: 03.2021 till 11.2022 ]
    • Parameters of FVC (liters, percentage of predicted) (the mean value, the standard deviation) before bronchodilator in patients with severe asthma at the 3year of follow-up

  40. • Parameters of FEV1 (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 3 year of follow-up [ Time Frame: 03.2021 till 11.2022 ]
    • Parameters of FEV1 (liters, percentage of predicted) (the mean value, the standard deviation) post bronchodilator in patients with severe asthma at the 3 year of follow-up

  41. • Parameters of FVC (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 3year of follow-up [ Time Frame: 03.2021 till 11.2022 ]
    • Parameters of FVC (liters, percentage of predicted) (the mean value, the standard deviation) post bronchodilator in patients with severe asthma at the 3year of follow-up

  42. • Parameters of FEV1 (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 4 year of follow-up [ Time Frame: 03.2022 till 11.2022 ]
    • Parameters of FEV1 (liters, percentage of predicted) (the mean value, the standard deviation) before bronchodilator in patients with severe asthma at the 4 year of follow-up

  43. • Parameters of FVC (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 4 year of follow-up [ Time Frame: 03.2022 till 11.2022 ]
    • Parameters of FVC (liters, percentage of predicted) (the mean value, the standard deviation) before bronchodilator in patients with severe asthma at the 4 year of follow-up

  44. • Parameters of FEV1 (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 4 year of follow-up; [ Time Frame: 03.2022 till 11.2022 ]
    • Parameters of FEV1 (liters, percentage of predicted) (the mean value, the standard deviation) post bronchodilator in patients with severe asthma at the 4 year of follow-up;

  45. • Parameters of FVC (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 4 year of follow-up; [ Time Frame: 03.2022 till 11.2022 ]
    • Parameters of FVC (liters, percentage of predicted) (the mean value, the standard deviation) post bronchodilator in patients with severe asthma at the 4 year of follow-up;

  46. • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the time of study enrollment; [ Time Frame: 03.2018 till 11.2022 ]

    • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the time of study enrollment (medians, percentilies); THE ASTHMA CONTROL QUESTIONNAIRE (ACQ) The ACQ has 6 questions. In questions 1-6, patients recall their experiences during the previous 7 days and respond using a 6-point scale (0=totally controlled to 6=extremely poorly controlled).

    INTERPRETING ACQ SCORES Patients with a score of 0.75 or lower have adequately controlled asthma. Between 0.75 and 1.5 is a grey area where patients are on the borderline of adequate control. Scores over 1.5 are a strong indication of inadequate control. If a patient's score increases or decreases by greater than 0.5 between assessments, the change can be considered clinically important (justifying a change in treatment).

    SHORT-ACTING β2 AGONIST (SABA) USE NOT AVAILABLE If patients do not use a SABA, question 6 may be omitted and the mean score calculated using questions 1-5 (total score / 5).


  47. • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 1 year of follow-up; [ Time Frame: 03.2019 till 11.2022 ]

    Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 1 year of follow-up (medians, percentilies); THE ASTHMA CONTROL QUESTIONNAIRE (ACQ) The ACQ has 6 questions. In questions 1-6, patients recall their experiences during the previous 7 days and respond using a 6-point scale (0=totally controlled to 6=extremely poorly controlled).

    INTERPRETING ACQ SCORES Patients with a score of 0.75 or lower have adequately controlled asthma. Between 0.75 and 1.5 is a grey area where patients are on the borderline of adequate control. Scores over 1.5 are a strong indication of inadequate control. If a patient's score increases or decreases by greater than 0.5 between assessments, the change can be considered clinically important (justifying a change in treatment).

    SHORT-ACTING β2 AGONIST (SABA) USE NOT AVAILABLE If patients do not use a SABA, question 6 may be omitted and the mean score calculated using questions 1-5 (total score / 5).


  48. • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 2 year of follow-up; [ Time Frame: 03.2020 till 11.2022 ]

    Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 2 year of follow-up (medians, percentilies); THE ASTHMA CONTROL QUESTIONNAIRE (ACQ) The ACQ has 6 questions. In questions 1-6, patients recall their experiences during the previous 7 days and respond using a 6-point scale (0=totally controlled to 6=extremely poorly controlled).

    INTERPRETING ACQ SCORES Patients with a score of 0.75 or lower have adequately controlled asthma. Between 0.75 and 1.5 is a grey area where patients are on the borderline of adequate control. Scores over 1.5 are a strong indication of inadequate control. If a patient's score increases or decreases by greater than 0.5 between assessments, the change can be considered clinically important (justifying a change in treatment).

    SHORT-ACTING β2 AGONIST (SABA) USE NOT AVAILABLE If patients do not use a SABA, question 6 may be omitted and the mean score calculated using questions 1-5 (total score / 5).


  49. • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 3 year of follow-up; [ Time Frame: 03.2021 till 11.2022 ]

    Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 3 year of follow-up (medians, percentilies); THE ASTHMA CONTROL QUESTIONNAIRE (ACQ) The ACQ has 6 questions. In questions 1-6, patients recall their experiences during the previous 7 days and respond using a 6-point scale (0=totally controlled to 6=extremely poorly controlled).

    INTERPRETING ACQ SCORES Patients with a score of 0.75 or lower have adequately controlled asthma. Between 0.75 and 1.5 is a grey area where patients are on the borderline of adequate control. Scores over 1.5 are a strong indication of inadequate control. If a patient's score increases or decreases by greater than 0.5 between assessments, the change can be considered clinically important (justifying a change in treatment).

    SHORT-ACTING β2 AGONIST (SABA) USE NOT AVAILABLE If patients do not use a SABA, question 6 may be omitted and the mean score calculated using questions 1-5 (total score / 5).


  50. • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 4 year of follow-up; [ Time Frame: 03.2022 till 11.2022 ]

    Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 4 year of follow-up (medians, percentilies); THE ASTHMA CONTROL QUESTIONNAIRE (ACQ) The ACQ has 6 questions. In questions 1-6, patients recall their experiences during the previous 7 days and respond using a 6-point scale (0=totally controlled to 6=extremely poorly controlled).

    INTERPRETING ACQ SCORES Patients with a score of 0.75 or lower have adequately controlled asthma. Between 0.75 and 1.5 is a grey area where patients are on the borderline of adequate control. Scores over 1.5 are a strong indication of inadequate control. If a patient's score increases or decreases by greater than 0.5 between assessments, the change can be considered clinically important (justifying a change in treatment).

    SHORT-ACTING β2 AGONIST (SABA) USE NOT AVAILABLE If patients do not use a SABA, question 6 may be omitted and the mean score calculated using questions 1-5 (total score / 5).


  51. • Number of exacerbations requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the time of study enrollment; [ Time Frame: 03.2018 till 11.2022 ]
    • Number of exacerbations (the mean value, the standard deviation) requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the time of study enrollment;

  52. • Number of exacerbations requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 1year of follow-up; [ Time Frame: 03.2019 till 11.2022 ]
    Number of exacerbations (the mean value, the standard deviation) requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 1year of follow-up;

  53. • Number of exacerbations requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 2year of follow-up; [ Time Frame: 03.2020 till 11.2022 ]
    Number of exacerbations (the mean value, the standard deviation) requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 2year of follow-up;

  54. • Number of exacerbations requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 3 year of follow-up; [ Time Frame: 03.2021 till 11.2022 ]
    Number of exacerbations (the mean value, the standard deviation) requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 3 year of follow-up;

  55. • Number of exacerbations requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 4 year of follow-up; [ Time Frame: 03.2022 till 11.2022 ]
    Number of exacerbations (the mean value, the standard deviation) requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 4 year of follow-up;

  56. • Number of hospitalizations in patients with severe asthma at the time of inclusion in the study; [ Time Frame: 03.2018 till 11.2022 ]
    • Number of hospitalizations (the mean value, the standard deviation) in patients with severe asthma at the time of inclusion in the study;

  57. • Number of hospitalizations in patients with severe asthma at the time of inclusion in the 1 year of follow-up; [ Time Frame: 03.2019 till 11.2022 ]
    • Number of hospitalizations (the mean value, the standard deviation) in patients with severe asthma at the time of inclusion in the 1 year of follow-up;

  58. • Number of hospitalizations in patients with severe asthma at the time of inclusion in the 2 year of follow-up; [ Time Frame: 03.2020 till 11.2022 ]
    • Number of hospitalizations (the mean value, the standard deviation) in patients with severe asthma at the time of inclusion in the 2 year of follow-up;

  59. • Number of hospitalizations in patients with severe asthma at the time of inclusion in the 3 year of follow-up; [ Time Frame: 03.2021 till 11.2022 ]
    • Number of hospitalizations (the mean value, the standard deviation) in patients with severe asthma at the time of inclusion in the 3 year of follow-up;

  60. • Number of hospitalizations in patients with severe asthma at the time of inclusion in the 4 year of follow-up; [ Time Frame: 03.2022 till 11.2022 ]
    • Number of hospitalizations (the mean value, the standard deviation) in patients with severe asthma at the time of inclusion in the 4 year of follow-up;

  61. • 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; [ Time Frame: 03.2018 till 11.2022 ]
    • Percentage of patients with severe asthma (the mean value, the standard deviation) taking high doses of ICS/LABA, ICS/LABA+LAMA as maintenance therapy, biologics at the time of study enrollment;

  62. • 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; [ Time Frame: 03.2019 till 11.2022 ]
    • Percentage of patients with severe asthma (the mean value, the standard deviation) taking high doses of ICS/LABA, ICS/LABA+LAMA as maintenance therapy, biologics at the 1 year of follow-up;

  63. • 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; [ Time Frame: 03.2020 till 11.2022 ]
    • Percentage of patients with severe asthma (the mean value, the standard deviation) taking high doses of ICS/LABA, ICS/LABA+LAMA as maintenance therapy, biologics at the 2 year of follow-up;

  64. • 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; [ Time Frame: 03.2021 till 11.2022 ]
    • Percentage of patients with severe asthma (the mean value, the standard deviation) taking high doses of ICS/LABA, ICS/LABA+LAMA as maintenance therapy, biologics at the 3 year of follow-up;

  65. • 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; [ Time Frame: 03.2022 till 11.2022 ]
    • Percentage of patients with severe asthma (the mean value, the standard deviation) taking high doses of ICS/LABA, ICS/LABA+LAMA as maintenance therapy, biologics at the 4 year of follow-up;

  66. • Percentage of patients with severe asthma taking OCS as a maintenance therapy at the time of study enrollment; [ Time Frame: 03.2018 till 11.2022 ]
    • Percentage of patients with severe asthma (the mean value, the standard deviation) taking OCS as a maintenance therapy at the time of study enrollment;

  67. • Percentage of patients with severe asthma taking OCS as a maintenance therapy at the 1 year of follow-up; [ Time Frame: 03.2019 till 11.2022 ]
    • Percentage of patients with severe asthma (the mean value, the standard deviation) taking OCS as a maintenance therapy at the 1 year of follow-up;

  68. • Percentage of patients with severe asthma taking OCS as a maintenance therapy at the 2 year of follow-up; [ Time Frame: 03.2020 till 11.2022 ]
    • Percentage of patients with severe asthma (the mean value, the standard deviation) taking OCS as a maintenance therapy at the 2 year of follow-up;

  69. • Percentage of patients with severe asthma taking OCS as a maintenance therapy at the 3 year of follow-up; [ Time Frame: 03.2021 till 11.2022 ]
    • Percentage of patients with severe asthma (the mean value, the standard deviation) taking OCS as a maintenance therapy at the 3 year of follow-up;

  70. • Percentage of patients with severe asthma taking OCS as a maintenance therapy at the 4 year of follow-up; [ Time Frame: 03.2022 till 11.2022 ]
    • Percentage of patients with severe asthma (the mean value, the standard deviation) taking OCS as a maintenance therapy at the 4 year of follow-up;

  71. • Percentage of patients with severe asthma who have been changed therapy to 1 year of follow-up; [ Time Frame: 03.2019 till 11.2022 ]
    • Percentage of patients with severe asthma (the mean value, the standard deviation) who have been changed therapy (step up, step down by GINA) to 1 year of follow-up;

  72. • Percentage of patients with severe asthma who have been changed therapy to 2 year of follow-up; [ Time Frame: 03.2020 till 11.2022 ]
    • Percentage of patients with severe asthma (the mean value, the standard deviation) who have been changed therapy (step up, step down by GINA) to 2 year of follow-up;

  73. • Percentage of patients with severe asthma who have been changed therapy to 3 year of follow-up; [ Time Frame: 03.2021 till 11.2022 ]
    • Percentage of patients with severe asthma (the mean value, the standard deviation) who have been changed therapy (step up, step down by GINA) to 3 year of follow-up;

  74. • Percentage of patients with severe asthma who have been changed therapy to 4 year of follow-up; [ Time Frame: 03.2022 till 11.2022 ]
    • Percentage of patients with severe asthma (the mean value, the standard deviation) who have been changed therapy (step up, step down by GINA) to 4 year of follow-up;

  75. • Percentage of patients with severe asthma who called for emergency medical care for asthma at the 1 year of follow-up; [ Time Frame: 03.2019 till 11.2022 ]
    • Percentage of patients with severe asthma who called for emergency medical care for asthma (number of observations, the mean value, the standard deviation, median) at the 1 year of follow-up;

  76. • Percentage of patients with severe asthma who called for emergency medical care for asthma at the 2 year of follow-up; [ Time Frame: 03.2020 till 11.2022 ]
    • Percentage of patients with severe asthma who called for emergency medical care for asthma (number of observations, the mean value, the standard deviation, median) at the 2 year of follow-up;

  77. • Percentage of patients with severe asthma who called for emergency medical care for asthma at the 3 year of follow-up; [ Time Frame: 03.2021 till 11.2022 ]
    • Percentage of patients with severe asthma who called for emergency medical care for asthma (number of observations, the mean value, the standard deviation, median) at the 3 year of follow-up;

  78. • Percentage of patients with severe asthma who called for emergency medical care for asthma at the 4 year of follow-up; [ Time Frame: 03.2022 till 11.2022 ]
    • Percentage of patients with severe asthma who called for emergency medical care for asthma (number of observations, the mean value, the standard deviation, median) at the 4 year of follow-up;

  79. • Percentage of patients with severe asthma who had disability sheets for asthma at the 1year of follow-up; [ Time Frame: 03.2019 till 11.2022 ]
    • Percentage of patients with severe asthma who had disability sheets for asthma (number of observations, the mean value, the standard deviation, median) at the 1year of follow-up;

  80. • Percentage of patients with severe asthma who had disability sheets for asthma at the 2 year of follow-up; [ Time Frame: 03.2020 till 11.2022 ]
    • Percentage of patients with severe asthma who had disability sheets for asthma (number of observations, the mean value, the standard deviation, median) at the 2 year of follow-up;

  81. • Percentage of patients with severe asthma who had disability sheets for asthma at the 3 year of follow-up; [ Time Frame: 03.2021 till 11.2022 ]
    • Percentage of patients with severe asthma who had disability sheets for asthma (number of observations, the mean value, the standard deviation, median) at the 3 year of follow-up;

  82. • Percentage of patients with severe asthma who had disability sheets for asthma at the 4 year of follow-up; [ Time Frame: 03.2022 till 11.2022 ]
    • Percentage of patients with severe asthma who had disability sheets for asthma (number of observations, the mean value, the standard deviation, median) at the 4 year of follow-up;


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608566


Contacts
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Contact: Andrey S Belevskiy, Ph.D. +79852336400 pulmobas@yandex.ru
Contact: Natalia M Nenasheva, Ph.D. +79037236927 1444031@gmail.com

Locations
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Russian Federation
City hospital 52 Recruiting
Moscow, Russian Federation, 123182
Contact: Natalia M Nenasheva, PhD    +79037236927    1444031@gmail.com   
Sponsors and Collaborators
Interregional Public Organization, Russian Respiratory Society
AstraZeneca Pharmaceuticals" LLC
Limited Liability Company Regional United System of Medical Informatization
Investigators
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Study Chair: Andrey S Belevskiy, Ph.D. Russian Respiratory Society
  Study Documents (Full-Text)

Documents provided by Interregional Public Organization, Russian Respiratory Society:
Study Protocol and Statistical Analysis Plan  [PDF] July 19, 2018

More Information
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Additional Information:

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Responsible Party: Interregional Public Organization, Russian Respiratory Society
ClinicalTrials.gov Identifier: NCT03608566    
Other Study ID Numbers: ESR-17-13479
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Interregional Public Organization, Russian Respiratory Society:
severe asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases