Clinical trial NCT01273363: Non-interventional Retrospective Multicenter Study of Patients With Bronchial Asthma During a Routine Visit to Out of Patients' Clinics
Official title: Non-interventional Retrospective Multicenter Study of Patients With Bronchial Asthma During a Routine Visit to Out of Patients' Clinics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Asthma in Children
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-01-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical practice

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


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 1 visit for 3 month
Secondary outcomes:
measure: To determine the main demographic, clinical and pharmacoepidemiological characteristics of low-control patients.
timeFrame: 1 visit for 3 month
measure: 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
timeFrame: 1 visit for 3 month
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: N.Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: St.Petersburg
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Alexey Stepanov, Prof.
role: STUDY_DIRECTOR
References: