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:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01273363
First received: January 7, 2011
Last updated: February 27, 2012
Last verified: February 2012
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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
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 Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013