CClinicalTrials.gg
Status unknownNCT03608566RSARUpdated Aug 10, 2018

Russian Severe Asthma Registry

An observational study in Severe Asthma, sponsored by Interregional Public Organization, Russian Respiratory Society. Status unknown at 1 site in Russian Federation. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-08-10.

Sponsored by Interregional Public Organization, Russian Respiratory Society · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7,000
Ages
12 Years and older
Sex
All
01

Study summary

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

Read the 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".

02

Conditions studied

  • Severe Asthma

Browse trials for

Keywords

  • severe asthma
03

In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's planned enrollment of 7,000 is above the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Interregional Public Organization, Russian Respiratory Society is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. • Percentage of patients with severe asthma according frequency of exacerbations at the time of study enrollment

    Percentage of patients with severe asthma according frequency of exacerbations (1, 2, ≥3 exacerbations) at the time of study enrollment

    Time frame: 03.2018 till 11.2022.

Secondary outcomes

  1. • Percentage of patients with severe asthma according frequency of exacerbations at the 1 year of follow-up;

    • Percentage of patients with severe asthma according frequency of exacerbations (1, 2, ≥3 exacerbations) at the 1 year of follow-up;

    Time frame: 03.2019 till 11.2022.

  2. Percentage of patients with severe asthma according frequency of exacerbations at the 2 year of follow-up;

    • Percentage of patients with severe asthma according frequency of exacerbations (1, 2, ≥3 exacerbations) at the 2 year of follow-up;

    Time frame: 03.2020 till 11.2022.

  3. • Percentage of patients with severe asthma according frequency of exacerbations at the 3 year of follow-up;

    • • Percentage of patients with severe asthma according frequency of exacerbations (1, 2, ≥3 exacerbations) at the 3 year of follow-up;

    Time frame: 03.2021 till 11.2022.

  4. • Percentage of patients with severe asthma according frequency of exacerbations (1, 2, ≥3 exacerbations) at the 4 year of follow-up;

    • 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.

  5. • Percentage of patients with severe asthma according concomitant diseases at the time of study enrollment

    • Percentage of patients with severe asthma according concomitant diseases (number of observations, the mean value, the standard deviation) at the time of study enrollment

    Time frame: 03.2018 till 11.2022.

  6. • Percentage of patients with severe asthma according concomitant diseases at the 1year of follow-up;

    • Percentage of patients with severe asthma according concomitant diseases (number of observations, the mean value, the standard deviation) at the 1year of follow-up;

    Time frame: 03.2019 till 11.2022.

  7. • Percentage of patients with severe asthma according concomitant diseases at the 2 year of follow-up;

    • 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;

    Time frame: 03.2020 till 11.2022

  8. • Percentage of patients with severe asthma according concomitant diseases at the 3 year of follow-up;

    • 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;

    Time frame: 03.2021 till 11.2022

  9. • Percentage of patients with severe asthma according concomitant diseases at the 4 year of follow-up;

    • 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;

    Time frame: 03.2022 till 11.2022

  10. • • Percentage of patients with severe asthma according to parameters: age at the time of study enrollment;

    • • Percentage of patients with severe asthma according to parameters: age (the mean value, the standard deviation) at the time of study enrollment;

    Time frame: 03.2018 till 11.2022

  11. • • Percentage of patients with severe asthma according to parameters: sex at the time of study enrollment;

    • • Percentage of patients with severe asthma according to parameters: sex at the time of study enrollment;

    Time frame: 03.2018 till 11.2022

  12. • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) at the time of enrollment

    • 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

    Time frame: 03.2018 till 11.2022

  13. • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) at the 1year of follow-up;

    • 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;

    Time frame: 03.2019 till 11.2022

  14. • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) at the 2year of follow-up;

    • 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;

    Time frame: 03.2020 till 11.2022

  15. • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) at the 3 year of follow-up;

    • 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;

    Time frame: 03.2021 till 11.2022

  16. • Percentage of patients with severe asthma with different phenotypes in terms of parameters: IgE (IU/ml) at the 4 year of follow-up;

    • 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;

    Time frame: 03.2022 till 11.2022

  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;

    • 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;

    Time frame: 03.2018 till 11.2022

  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;

    • 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;

    Time frame: 03.2019 till 11.2022

  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;

    • 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;

    Time frame: 03.2020 till 11.2022

  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;

    • 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;

    Time frame: 03.2021 till 11.2022

  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;

    • 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;

    Time frame: 03.2022 till 11.2022

  22. • The parameters of body mass index in the patients with severe asthma at the time of study enrollment;

    • 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)

    Time frame: 03.2018 till 11.2022

  23. • Percentage of patients with severe asthma in the parameters: of smoking at the time of study enrollment;

    • Percentage of patients with severe asthma in the parameters: of smoking (smoker's index (pack-years)) at the time of study enrollment;

    Time frame: 03.2018 till 11.2022

  24. • Percentage of patients with severe asthma in the parameters: of professional history at the time of study enrollment;

    • 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;

    Time frame: 03.2018 till 11.2022

  25. • Percentage of patients with severe asthma in the parameters: of family history at the time of study enrollment;

    • 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

    Time frame: 03.2018 till 11.2022

  26. • Parameters of FEV1 (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the time of study enrollment;

    • 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;

    Time frame: 03.2018 till 11.2022

  27. • Parameters of FVC (liters, percentage of predicted)before bronchodilator in patients with severe asthma at the time of study enrollment

    • 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

    Time frame: 03.2018 till 11.2022

  28. • Parameters of FEV1 (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the time of study enrollment;

    • 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;

    Time frame: 03.2018 till 11.2022

  29. • Parameters of FVC (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the time of study enrollment;

    • 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;

    Time frame: 03.2018 till 11.2022

  30. • Parameters of FEV1 (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 1 year of follow-up

    • 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

    Time frame: 03.2019 till 11.2022

  31. • Parameters of FVC (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 1year of follow-up;

    • 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;

    Time frame: 03.2019 till 11.2022

  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;

    • Parameters of FEV1 (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 1 year of follow-up;

    Time frame: 03.2019 till 11.2022

  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;

    • Parameters of FVC (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 1year of follow-up;

    Time frame: 03.2019 till 11.2022

  34. • Parameters of FEV1 (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 2 year of follow-up;

    • 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;

    Time frame: 03.2020 till 11.2022

  35. • Parameters of FVC (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 2year of follow-up;

    • 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;

    Time frame: 03.2020 till 11.2022

  36. • Parameters of FEV1 (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 2 year of follow-up;

    • 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;

    Time frame: 03.2020 till 11.2022

  37. • Parameters of FVC (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 2year of follow-up;

    • 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;

    Time frame: 03.2020 till 11.2022

  38. • Parameters of FEV1 (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 3 year of follow-up

    • 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

    Time frame: 03.2021 till 11.2022

  39. • Parameters of FVC (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 3year of follow-up

    • 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

    Time frame: 03.2021 till 11.2022

  40. • Parameters of FEV1 (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 3 year of follow-up

    • 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

    Time frame: 03.2021 till 11.2022

  41. • Parameters of FVC (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 3year of follow-up

    • 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

    Time frame: 03.2021 till 11.2022

  42. • Parameters of FEV1 (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 4 year of follow-up

    • 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

    Time frame: 03.2022 till 11.2022

  43. • Parameters of FVC (liters, percentage of predicted) before bronchodilator in patients with severe asthma at the 4 year of follow-up

    • 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

    Time frame: 03.2022 till 11.2022

  44. • Parameters of FEV1 (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 4 year of follow-up;

    • 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;

    Time frame: 03.2022 till 11.2022

  45. • Parameters of FVC (liters, percentage of predicted) post bronchodilator in patients with severe asthma at the 4 year of follow-up;

    • 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;

    Time frame: 03.2022 till 11.2022

  46. • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the time of study enrollment;

    • 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).

    Time frame: 03.2018 till 11.2022

  47. • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 1 year of follow-up;

    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).

    Time frame: 03.2019 till 11.2022

  48. • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 2 year of follow-up;

    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).

    Time frame: 03.2020 till 11.2022

  49. • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 3 year of follow-up;

    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).

    Time frame: 03.2021 till 11.2022

  50. • Parameters of the analysis of the questionnaire ACQ-6 in patients with severe asthma at the 4 year of follow-up;

    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).

    Time frame: 03.2022 till 11.2022

  51. • Number of exacerbations requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the time of study enrollment;

    • 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;

    Time frame: 03.2018 till 11.2022

  52. • Number of exacerbations requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 1year of follow-up;

    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;

    Time frame: 03.2019 till 11.2022

  53. • Number of exacerbations requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 2year of follow-up;

    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;

    Time frame: 03.2020 till 11.2022

  54. • Number of exacerbations requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 3 year of follow-up;

    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;

    Time frame: 03.2021 till 11.2022

  55. • Number of exacerbations requiring medical attention (outpatient prescription of systemic corticosteroids) in patients with severe asthma at the 4 year of follow-up;

    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;

    Time frame: 03.2022 till 11.2022

  56. • Number of hospitalizations in patients with severe asthma at the time of inclusion in the study;

    • Number of hospitalizations (the mean value, the standard deviation) in patients with severe asthma at the time of inclusion in the study;

    Time frame: 03.2018 till 11.2022

  57. • Number of hospitalizations in patients with severe asthma at the time of inclusion in the 1 year of follow-up;

    • 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;

    Time frame: 03.2019 till 11.2022

  58. • Number of hospitalizations in patients with severe asthma at the time of inclusion in the 2 year of follow-up;

    • 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;

    Time frame: 03.2020 till 11.2022

  59. • Number of hospitalizations in patients with severe asthma at the time of inclusion in the 3 year of follow-up;

    • 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;

    Time frame: 03.2021 till 11.2022

  60. • Number of hospitalizations in patients with severe asthma at the time of inclusion in the 4 year of follow-up;

    • 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;

    Time frame: 03.2022 till 11.2022

  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;

    • 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;

    Time frame: 03.2018 till 11.2022

  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;

    • 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;

    Time frame: 03.2019 till 11.2022

  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;

    • 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;

    Time frame: 03.2020 till 11.2022

  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;

    • 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;

    Time frame: 03.2021 till 11.2022

  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;

    • 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;

    Time frame: 03.2022 till 11.2022

  66. • Percentage of patients with severe asthma taking OCS as a maintenance therapy at the time of study enrollment;

    • Percentage of patients with severe asthma (the mean value, the standard deviation) taking OCS as a maintenance therapy at the time of study enrollment;

    Time frame: 03.2018 till 11.2022

  67. • Percentage of patients with severe asthma taking OCS as a maintenance therapy at the 1 year of follow-up;

    • 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;

    Time frame: 03.2019 till 11.2022

  68. • Percentage of patients with severe asthma taking OCS as a maintenance therapy at the 2 year of follow-up;

    • 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;

    Time frame: 03.2020 till 11.2022

  69. • Percentage of patients with severe asthma taking OCS as a maintenance therapy at the 3 year of follow-up;

    • 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;

    Time frame: 03.2021 till 11.2022

  70. • Percentage of patients with severe asthma taking OCS as a maintenance therapy at the 4 year of follow-up;

    • 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;

    Time frame: 03.2022 till 11.2022

  71. • Percentage of patients with severe asthma who have been changed therapy to 1 year of follow-up;

    • 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;

    Time frame: 03.2019 till 11.2022

  72. • Percentage of patients with severe asthma who have been changed therapy to 2 year of follow-up;

    • 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;

    Time frame: 03.2020 till 11.2022

  73. • Percentage of patients with severe asthma who have been changed therapy to 3 year of follow-up;

    • 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;

    Time frame: 03.2021 till 11.2022

  74. • Percentage of patients with severe asthma who have been changed therapy to 4 year of follow-up;

    • 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;

    Time frame: 03.2022 till 11.2022

  75. • Percentage of patients with severe asthma who called for emergency medical care for asthma at the 1 year of follow-up;

    • 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;

    Time frame: 03.2019 till 11.2022

  76. • Percentage of patients with severe asthma who called for emergency medical care for asthma at the 2 year of follow-up;

    • 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;

    Time frame: 03.2020 till 11.2022

  77. • Percentage of patients with severe asthma who called for emergency medical care for asthma at the 3 year of follow-up;

    • 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;

    Time frame: 03.2021 till 11.2022

  78. • Percentage of patients with severe asthma who called for emergency medical care for asthma at the 4 year of follow-up;

    • 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;

    Time frame: 03.2022 till 11.2022

  79. • Percentage of patients with severe asthma who had disability sheets for asthma at the 1year of follow-up;

    • 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;

    Time frame: 03.2019 till 11.2022

  80. • Percentage of patients with severe asthma who had disability sheets for asthma at the 2 year of follow-up;

    • 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;

    Time frame: 03.2020 till 11.2022

  81. • Percentage of patients with severe asthma who had disability sheets for asthma at the 3 year of follow-up;

    • 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;

    Time frame: 03.2021 till 11.2022

  82. • Percentage of patients with severe asthma who had disability sheets for asthma at the 4 year of follow-up;

    • 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;

    Time frame: 03.2022 till 11.2022

07

Study locations

1 of 1 sites recruiting
  • City hospital 52
    Moscow, 123182, Russian Federation
    Recruiting
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 19, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03608566
Lead sponsor
Interregional Public Organization, Russian Respiratory Society
Collaborators
AstraZeneca, Limited Liability Company Regional United System of Medical Informatization
Responsible party
Sponsor
First posted
Aug 1, 2018
Start date
Mar 30, 2018
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Aug 10, 2018

Study contacts

Andrey S Belevskiy, Ph.D.
Contact
pulmobas@yandex.ru
+79852336400
Natalia M Nenasheva, Ph.D.
Contact
1444031@gmail.com
+79037236927
Andrey S Belevskiy, Ph.D.
study chair · Russian Respiratory Society

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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