Non-interventional Retrospective Multicenter Study of Patients With Bronchial Asthma During a Routine Visit to Out of Patients' Clinics
NIKA
1 other identifier
observational
1,000
1 country
12
Brief Summary
To assess asthma control in Russian patients according to the new criteria provided in the international guidelines and identify pharmacological approaches that provide a higher level of overall asthma control
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2010
Shorter than P25 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 7, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFebruary 28, 2012
February 1, 2012
5 months
January 7, 2011
February 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess asthma control in Russian patients acc. to the new criteria in the international guidelines (Standardizing Endpoints for Clinical Asthma Trials and Clinical Practice) and identify pharmacological approaches provided a higher level of control
1 visit for 3 month
Secondary Outcomes (2)
To determine the main demographic, clinical and pharmacoepidemiological characteristics of low-control patients.
1 visit for 3 month
To assess comparative value of the Asthma Control Questionnaire (ACT) and Asthma Control Questionnaire (ACQ) with regard to their use in clinical practice in Russia
1 visit for 3 month
Study Arms (1)
1
Male and female over 18. Patients with asthma diagnosed in accordance with the Global Initiative for Asthma within 6 months before inclusion into the study and without changes in treatment for 2 months before inclusion
Eligibility Criteria
Clinical practice
You may qualify if:
- Male and female patients over 18 years of age
- Patients who signed their informed consents to collection and further processing of data on their disease course
You may not qualify if:
- Patients on β-blockers.
- Patients with COPD, mucoviscidosis or bronchiectasis, Severe heart failure (NYHA functional class III-IV), Renal insufficiency, Cancer, Previous stroke.
- Pregnant women.
- Patients following a major surgery, Hepatic insufficiency.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (12)
Research Site
Chelyabinsk, Russia
Research Site
Irkutsk, Russia
Research Site
Krasnodar, Russia
Research Site
Krasnoyarsk, Russia
Research Site
Moscow, Russia
Research Site
N.Novgorod, Russia
Research Site
Novosibirsk, Russia
Research Site
Perm, Russia
Research Site
Rostov-on-Don, Russia
Research Site
Saint Petersburg, Russia
Research Site
Ufa, Russia
Research Site
Yekaterinburg, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alexey Stepanov, Prof.
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2011
First Posted
January 10, 2011
Study Start
December 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
February 28, 2012
Record last verified: 2012-02