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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01273363
First Posted: January 10, 2011
Last Update Posted: February 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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

Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Non-interventional Retrospective Multicenter Study of Patients With Bronchial Asthma During a Routine Visit to Out of Patients' Clinics

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To determine the main demographic, clinical and pharmacoepidemiological characteristics of low-control patients. [ Time Frame: 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 [ Time Frame: 1 visit for 3 month ]

Enrollment: 1000
Study Start Date: December 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clinical practice
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273363


Locations
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, Russian Federation
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Alexey Stepanov, Prof. AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01273363     History of Changes
Other Study ID Numbers: NIS-RRU-DUM-2010/1
First Submitted: January 7, 2011
First Posted: January 10, 2011
Last Update Posted: February 28, 2012
Last Verified: February 2012

Keywords provided by AstraZeneca:
Asthma
Asthma in Children

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases