Non-interventional Retrospective Multicenter Study of Patients With Bronchial Asthma During a Routine Visit to Out of Patients' Clinics

AstraZeneca1 site in 1 country1,000 target enrollmentDecember 2010

ConditionsAsthma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Asthma
Sponsor: AstraZeneca
Enrollment: 1000
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

May 2011

Last Updated

14 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female patients over 18 years of age
•Patients with asthma diagnosed in accordance with the Global Initiative for Asthma (GINA \[xv\]) within 6 months before inclusion into the study. Patients with no changes in their treatment within 2 months before inclusion into the study
•Patients who signed their informed consents to collection and further processing of data on their disease course

Exclusion Criteria

•Asthma patients with an exacerbation at the moment of inclusion.
•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.

Outcomes

Primary Outcomes

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

Time Frame: 1 visit for 3 month

Secondary Outcomes

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)