Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients
UFO
1 other identifier
observational
2,815
1 country
100
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2011
Shorter than P25 for all trials
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2011
CompletedFirst Posted
Study publicly available on registry
March 31, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJuly 25, 2011
July 1, 2011
March 28, 2011
July 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of packs of fixed combination prescribed to patients with asthma bronchiale in one year
1 year
Secondary Outcomes (2)
Asthma severity in patients treated with fixed combination
1 year
Strength/dose of prescribed fixed combination
1 year
Eligibility Criteria
Primary care clinic (specialists in allergology and pulmology)
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (100)
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Benešov, Czechia
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Beroun, Czechia
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Bílovec, Czechia
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Blansko, Czechia
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Blovice, Czechia
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Bohumín, Czechia
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Brandys N/L, Czechia
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Brno, Czechia
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Cheb, Czechia
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Chomutov, Czechia
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Chotěboř, Czechia
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Chrudim, Czechia
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Čáslav, Czechia
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Česká Lípa, Czechia
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České Budějovice, Czechia
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Český Krumlov, Czechia
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Český Těšín, Czechia
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Děčín, Czechia
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Domažlice, Czechia
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Fifejdy Ostrava, Czechia
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Fryštát, Czechia
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Frýdek-Místek, Czechia
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Havířov, Czechia
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Havlíčkův Brod, Czechia
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Holice, Czechia
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Horažďovice, Czechia
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Hořovice, Czechia
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Hradec Králové, Czechia
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Hranice, Czechia
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Jablonec N/N, Czechia
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Jilemnice, Czechia
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Jindřichův Hradec, Czechia
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Kadaň, Czechia
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Karlovy Vary, Czechia
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Kladno, Czechia
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Klatovy, Czechia
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Kolín, Czechia
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Kralupy N/V, Czechia
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Krnov, Czechia
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Kroměříž, Czechia
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Kutná Hora, Czechia
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Liberec, Czechia
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Litoměřice, Czechia
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Litomyšl, Czechia
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Litvnov, Czechia
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Lochovice, Czechia
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Lovosice, Czechia
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MarianskeLazne, Czechia
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Mělník, Czechia
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Mladá Boleslav, Czechia
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Mnichovo Hradiště, Czechia
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Most, Czechia
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Náchod, Czechia
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Neratovice, Czechia
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Nové Město na Moravě, Czechia
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Nový Jičín, Czechia
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Olomouc, Czechia
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Opava, Czechia
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Orlová, Czechia
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Ostrava, Czechia
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Ostrava - Hrabuvka, Czechia
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Pardubice, Czechia
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Pelhřimov, Czechia
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Pilsen, Czechia
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Písek, Czechia
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Poděbrady, Czechia
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Prachatice, Czechia
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Prague, Czechia
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Prostejov - Karlov, Czechia
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Prostějov, Czechia
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Přerov, Czechia
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Příbor, Czechia
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Příbram, Czechia
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Rakovník, Czechia
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Roudnice N/L, Czechia
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Rožnov pod Radhoštěm, Czechia
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Rychnov nad Kněžnou, Czechia
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Slaný, Czechia
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Sokolov, Czechia
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Stod, Czechia
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Strakonice, Czechia
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Svitavy, Czechia
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Šumperk, Czechia
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Tachov, Czechia
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Tábor, Czechia
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Teplice, Czechia
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Trutnov, Czechia
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Třebíč, Czechia
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Třemošná, Czechia
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Týn nad Vltavou, Czechia
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Ústí nad Labem, Czechia
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Valašské Meziříčí, Czechia
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Vsetín, Czechia
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Vyškov, Czechia
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Zdar, Czechia
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Zlín, Czechia
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Znojmo, Czechia
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Žamberk, Czechia
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Žatec, Czechia
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Železný Brod, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Viktor Kasak, MD
LERYMED spol. s.r.o.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 28, 2011
First Posted
March 31, 2011
Study Start
April 1, 2011
Study Completion
June 1, 2011
Last Updated
July 25, 2011
Record last verified: 2011-07