Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients

Completed

• Conditions: Asthma

• Registration Number: NCT01327001
• Lead Sponsor: AstraZeneca

Brief Summary

Moderate and severe asthma bronchiale is treated by fixed combination (budesonide/formoterol or salmeterol/fluticasone) in the Czech Republic.

There is a hypothesis that doctors should prescribe to each patients per year: six units of fixed combination budesonide/formoterol, or seven units of fixed combination budesonide/formoterol in approach SMART, or twelve units of fixed combination salmeterol/fluticasone. With regard to current prices the treatment by fixed combination budesonide/formoterol should cost less.

The investigators do not have any data about real life utilization of fixed combination in asthma treatment in Czech Republic The investigators propose to conduct a non-interventional multicentric retrospective epidemiological study looking into the patients records kept by specialist - allergists and pulmologists.

Retrospective data for eligible patients will be reviewed by participating investigators, physicians taking care of their patients, and recorded in the electronic CRF. Only patients who have been treated for asthma bronchiale (classification of severity - moderate or severe persistent asthma) with fixed combination for at least one year could be included into the study. There are no scheduled visits for any patient participating in the study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-30
• Study First Posted: 2011-03-31
• Study Start: 2011-04
• Study Completion: 2011-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-22
• Last Update Posted: 2011-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2815

Inclusion Criteria

• Male or female aged 6 years or over
• Asthma bronchiale, classification of severity - moderate or severe persistent
• Documented fixed combination (budesonide/formoterol or salmeterol/fluticasone) therapy for at least 18 months

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of packs of fixed combination prescribed to patients with asthma bronchiale in one year	1 year

Secondary Outcome Measures

Name	Time	Method
Asthma severity in patients treated with fixed combination	1 year
Strength/dose of prescribed fixed combination	1 year

Trial Locations

Locations (1)

Research Site; 🇨🇿 Znojmo, Czech Republic