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Completed

NCT Number: NCT01273363

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

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

Completed

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Chelyabinsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. To determine the main demographic, clinical and pharmacoepidemiological characteristics of low-control patients.

    Time frame: 1 visit for 3 month

  2. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: NIKA

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 10, 2011
Registry last updated
Feb 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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