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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01273363
First received: January 7, 2011
Last updated: February 27, 2012
Last verified: February 2012
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the main demographic, clinical and pharmacoepidemiological characteristics of low-control patients. [ Time Frame: 1 visit for 3 month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01273363     History of Changes
Other Study ID Numbers: NIS-RRU-DUM-2010/1
Study First Received: January 7, 2011
Last Updated: February 27, 2012
Health Authority: Russia: Ethics Committee

Keywords provided by AstraZeneca:
Asthma
Asthma in Children

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

ClinicalTrials.gov processed this record on October 20, 2014