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

Asthma Clinical Trial

— NIKA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01273363
• Other study ID #: NIS-RRU-DUM-2010/1
• Status: Completed
• Phase: N/A
• First received: January 7, 2011
• Last updated: February 27, 2012
• Start date: December 2010
• Est. completion date: May 2011

Study information

• Verified date: February 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß-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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Irkutsk
Russian Federation	Research Site	Krasnodar
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	N.Novgorod
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Perm
Russian Federation	Research Site	Rostov-on-Don
Russian Federation	Research Site	St.Petersburg
Russian Federation	Research Site	Ufa

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To determine the main demographic, clinical and pharmacoepidemiological characteristics of low-control patients.		1 visit for 3 month	No
Secondary	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	No