Clinical trial NCT01327001: Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients
Official title: Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients in Real Life Condition in Czech Republic (UFO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma bronchiale, fixed combination
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-03-31
Enrollment: 2815
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic (specialists in allergology and pulmology)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of packs of fixed combination prescribed to patients with asthma bronchiale in one year
timeFrame: 1 year
Secondary outcomes:
measure: Asthma severity in patients treated with fixed combination
timeFrame: 1 year
measure: Strength/dose of prescribed fixed combination
timeFrame: 1 year
Other outcomes:
Locations:
city: Benesov
country: Czech Republic
facility: Research Site
city: Beroun
country: Czech Republic
facility: Research Site
city: Bilovec
country: Czech Republic
facility: Research Site
city: Blansko
country: Czech Republic
facility: Research Site
city: Blovice
country: Czech Republic
facility: Research Site
city: Bohumin
country: Czech Republic
facility: Research Site
city: Brandys N/L
country: Czech Republic
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Caslav
country: Czech Republic
facility: Research Site
city: Ceska Lipa
country: Czech Republic
facility: Research Site
city: Ceske Budejovice
country: Czech Republic
facility: Research Site
city: Cesky Krumlov
country: Czech Republic
facility: Research Site
city: Cesky Tesin
country: Czech Republic
facility: Research Site
city: Cheb
country: Czech Republic
facility: Research Site
city: Chomutov
country: Czech Republic
facility: Research Site
city: Chotebor
country: Czech Republic
facility: Research Site
city: Chrudim
country: Czech Republic
facility: Research Site
city: Decin
country: Czech Republic
facility: Research Site
city: Domazlice
country: Czech Republic
facility: Research Site
city: Fifejdy Ostrava
country: Czech Republic
facility: Research Site
city: Frydek Mistek
country: Czech Republic
facility: Research Site
city: Havirov
country: Czech Republic
facility: Research Site
city: Havlickuv Brod
country: Czech Republic
facility: Research Site
city: Holice
country: Czech Republic
facility: Research Site
city: Horazdovice
country: Czech Republic
facility: Research Site
city: Horovice
country: Czech Republic
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Hranice
country: Czech Republic
facility: Research Site
city: Jablonec N/N
country: Czech Republic
facility: Research Site
city: Jilemnice
country: Czech Republic
facility: Research Site
city: Jindrichuv Hradec
country: Czech Republic
facility: Research Site
city: Kadan
country: Czech Republic
facility: Research Site
city: Karlovy Vary
country: Czech Republic
facility: Research Site
city: Karvina
country: Czech Republic
facility: Research Site
city: Kladno
country: Czech Republic
facility: Research Site
city: Klatovy
country: Czech Republic
facility: Research Site
city: Kolin
country: Czech Republic
facility: Research Site
city: Kralupy N/V
country: Czech Republic
facility: Research Site
city: Krnov
country: Czech Republic
facility: Research Site
city: Kromeriz
country: Czech Republic
facility: Research Site
city: Kutna Hora
country: Czech Republic
facility: Research Site
city: Liberec
country: Czech Republic
facility: Research Site
city: Litomerice
country: Czech Republic
facility: Research Site
city: Litomysl
country: Czech Republic
facility: Research Site
city: Litvnov
country: Czech Republic
facility: Research Site
city: Lochovice
country: Czech Republic
facility: Research Site
city: Lovosice
country: Czech Republic
facility: Research Site
city: MarianskeLazne
country: Czech Republic
facility: Research Site
city: Melnik
country: Czech Republic
facility: Research Site
city: Mlada Boleslav
country: Czech Republic
facility: Research Site
city: Mnichovo Hradiste
country: Czech Republic
facility: Research Site
city: Most
country: Czech Republic
facility: Research Site
city: Nachod
country: Czech Republic
facility: Research Site
city: Neratovice
country: Czech Republic
facility: Research Site
city: Nove Mesto na Morave
country: Czech Republic
facility: Research Site
city: Novy Jicin
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Opava
country: Czech Republic
facility: Research Site
city: Orlova
country: Czech Republic
facility: Research Site
city: Ostrava - Hrabuvka
country: Czech Republic
facility: Research Site
city: Ostrava
country: Czech Republic
facility: Research Site
city: Pardubice
country: Czech Republic
facility: Research Site
city: Pelhrimov
country: Czech Republic
facility: Research Site
city: Pisek
country: Czech Republic
facility: Research Site
city: Plzen
country: Czech Republic
facility: Research Site
city: Podebrady
country: Czech Republic
facility: Research Site
city: Prachatice
country: Czech Republic
facility: Research Site
city: Praha
country: Czech Republic
facility: Research Site
city: Prerov
country: Czech Republic
facility: Research Site
city: Pribor
country: Czech Republic
facility: Research Site
city: Pribram
country: Czech Republic
facility: Research Site
city: Prostejov - Karlov
country: Czech Republic
facility: Research Site
city: Prostejov
country: Czech Republic
facility: Research Site
city: Rakovnik
country: Czech Republic
facility: Research Site
city: Roudnice N/L
country: Czech Republic
facility: Research Site
city: Roznov pod Radhostem
country: Czech Republic
facility: Research Site
city: Rychnov nad Kneznou
country: Czech Republic
facility: Research Site
city: Slany
country: Czech Republic
facility: Research Site
city: Sokolov
country: Czech Republic
facility: Research Site
city: Stod
country: Czech Republic
facility: Research Site
city: Strakonice
country: Czech Republic
facility: Research Site
city: Sumperk
country: Czech Republic
facility: Research Site
city: Svitavy
country: Czech Republic
facility: Research Site
city: Tabor
country: Czech Republic
facility: Research Site
city: Tachov
country: Czech Republic
facility: Research Site
city: Teplice
country: Czech Republic
facility: Research Site
city: Trebic
country: Czech Republic
facility: Research Site
city: Tremosna
country: Czech Republic
facility: Research Site
city: Trutnov
country: Czech Republic
facility: Research Site
city: Tyn nad Vltavou
country: Czech Republic
facility: Research Site
city: Usti nad Labem
country: Czech Republic
facility: Research Site
city: Valasske Mezirici
country: Czech Republic
facility: Research Site
city: Vsetin
country: Czech Republic
facility: Research Site
city: Vyskov
country: Czech Republic
facility: Research Site
city: Zamberk
country: Czech Republic
facility: Research Site
city: Zatec
country: Czech Republic
facility: Research Site
city: Zdar nad Sazavou
country: Czech Republic
facility: Research Site
city: Zelezny Brod
country: Czech Republic
facility: Research Site
city: Zlin
country: Czech Republic
facility: Research Site
city: Znojmo
country: Czech Republic
facility: Research Site
Study officials:
affiliation: LERYMED spol. s.r.o.
name: Viktor Kasak, MD
role: PRINCIPAL_INVESTIGATOR
References: