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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01273363
Acronym
NIKA
Enrollment
1000
Registered
2011-01-10
Start date
2010-12-31
Completion date
2011-05-31
Last updated
2012-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Asthma in Children

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

Interventions

None listed

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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 control1 visit for 3 month

Secondary

MeasureTime frame
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 Russia1 visit for 3 month

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026