NCT03608566

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 10, 2018

Status Verified

July 1, 2018

Enrollment Period

4.8 years

First QC Date

May 4, 2018

Last Update Submit

August 8, 2018

Conditions

Keywords

severe asthma

Outcome Measures

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

    03.2018 till 11.2022.

Secondary Outcomes (82)

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

    03.2019 till 11.2022.

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

    03.2020 till 11.2022.

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

    03.2021 till 11.2022.

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

    03.2022 till 11.2022.

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

    03.2018 till 11.2022.

  • +77 more secondary outcomes

Eligibility Criteria

Age12 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City hospital 52

Moscow, 123182, Russia

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Andrey S Belevskiy, Ph.D.

    Russian Respiratory Society

    STUDY CHAIR

Central Study Contacts

Andrey S Belevskiy, Ph.D.

CONTACT

Natalia M Nenasheva, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2018

First Posted

August 1, 2018

Study Start

March 30, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 10, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations