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

Completed

• Conditions: Asthma

• Registration Number: NCT01273363
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-07
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-27
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇷🇺 Ufa, Russian Federation