Asthma Clinical Trial
— UFOOfficial 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)
| Verified date | July 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Czech Republic: State Institute for Drug Control |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 2815 |
| Est. completion date | June 2011 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Research Site | Benesov | |
| Czech Republic | Research Site | Beroun | |
| Czech Republic | Research Site | Bilovec | |
| Czech Republic | Research Site | Blansko | |
| Czech Republic | Research Site | Blovice | |
| Czech Republic | Research Site | Bohumin | |
| Czech Republic | Research Site | Brandys N/L | |
| Czech Republic | Research Site | Brno | |
| Czech Republic | Research Site | Caslav | |
| Czech Republic | Research Site | Ceska Lipa | |
| Czech Republic | Research Site | Ceske Budejovice | |
| Czech Republic | Research Site | Cesky Krumlov | |
| Czech Republic | Research Site | Cesky Tesin | |
| Czech Republic | Research Site | Cheb | |
| Czech Republic | Research Site | Chomutov | |
| Czech Republic | Research Site | Chotebor | |
| Czech Republic | Research Site | Chrudim | |
| Czech Republic | Research Site | Decin | |
| Czech Republic | Research Site | Domazlice | |
| Czech Republic | Research Site | Fifejdy Ostrava | |
| Czech Republic | Research Site | Frydek Mistek | |
| Czech Republic | Research Site | Havirov | |
| Czech Republic | Research Site | Havlickuv Brod | |
| Czech Republic | Research Site | Holice | |
| Czech Republic | Research Site | Horazdovice | |
| Czech Republic | Research Site | Horovice | |
| Czech Republic | Research Site | Hradec Kralove | |
| Czech Republic | Research Site | Hranice | |
| Czech Republic | Research Site | Jablonec N/N | |
| Czech Republic | Research Site | Jilemnice | |
| Czech Republic | Research Site | Jindrichuv Hradec | |
| Czech Republic | Research Site | Kadan | |
| Czech Republic | Research Site | Karlovy Vary | |
| Czech Republic | Research Site | Karvina | |
| Czech Republic | Research Site | Kladno | |
| Czech Republic | Research Site | Klatovy | |
| Czech Republic | Research Site | Kolin | |
| Czech Republic | Research Site | Kralupy N/V | |
| Czech Republic | Research Site | Krnov | |
| Czech Republic | Research Site | Kromeriz | |
| Czech Republic | Research Site | Kutna Hora | |
| Czech Republic | Research Site | Liberec | |
| Czech Republic | Research Site | Litomerice | |
| Czech Republic | Research Site | Litomysl | |
| Czech Republic | Research Site | Litvnov | |
| Czech Republic | Research Site | Lochovice | |
| Czech Republic | Research Site | Lovosice | |
| Czech Republic | Research Site | MarianskeLazne | |
| Czech Republic | Research Site | Melnik | |
| Czech Republic | Research Site | Mlada Boleslav | |
| Czech Republic | Research Site | Mnichovo Hradiste | |
| Czech Republic | Research Site | Most | |
| Czech Republic | Research Site | Nachod | |
| Czech Republic | Research Site | Neratovice | |
| Czech Republic | Research Site | Nove Mesto na Morave | |
| Czech Republic | Research Site | Novy Jicin | |
| Czech Republic | Research Site | Olomouc | |
| Czech Republic | Research Site | Opava | |
| Czech Republic | Research Site | Orlova | |
| Czech Republic | Research Site | Ostrava | |
| Czech Republic | Research Site | Ostrava - Hrabuvka | |
| Czech Republic | Research Site | Pardubice | |
| Czech Republic | Research Site | Pelhrimov | |
| Czech Republic | Research Site | Pisek | |
| Czech Republic | Research Site | Plzen | |
| Czech Republic | Research Site | Podebrady | |
| Czech Republic | Research Site | Prachatice | |
| Czech Republic | Research Site | Praha | |
| Czech Republic | Research Site | Prerov | |
| Czech Republic | Research Site | Pribor | |
| Czech Republic | Research Site | Pribram | |
| Czech Republic | Research Site | Prostejov | |
| Czech Republic | Research Site | Prostejov - Karlov | |
| Czech Republic | Research Site | Rakovnik | |
| Czech Republic | Research Site | Roudnice N/L | |
| Czech Republic | Research Site | Roznov pod Radhostem | |
| Czech Republic | Research Site | Rychnov nad Kneznou | |
| Czech Republic | Research Site | Slany | |
| Czech Republic | Research Site | Sokolov | |
| Czech Republic | Research Site | Stod | |
| Czech Republic | Research Site | Strakonice | |
| Czech Republic | Research Site | Sumperk | |
| Czech Republic | Research Site | Svitavy | |
| Czech Republic | Research Site | Tabor | |
| Czech Republic | Research Site | Tachov | |
| Czech Republic | Research Site | Teplice | |
| Czech Republic | Research Site | Trebic | |
| Czech Republic | Research Site | Tremosna | |
| Czech Republic | Research Site | Trutnov | |
| Czech Republic | Research Site | Tyn nad Vltavou | |
| Czech Republic | Research Site | Usti nad Labem | |
| Czech Republic | Research Site | Valasske Mezirici | |
| Czech Republic | Research Site | Vsetin | |
| Czech Republic | Research Site | Vyskov | |
| Czech Republic | Research Site | Zamberk | |
| Czech Republic | Research Site | Zatec | |
| Czech Republic | Research Site | Zdar nad Sazavou | |
| Czech Republic | Research Site | Zelezny Brod | |
| Czech Republic | Research Site | Zlin | |
| Czech Republic | Research Site | Znojmo |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Czech Republic,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of packs of fixed combination prescribed to patients with asthma bronchiale in one year | 1 year | No | |
| Secondary | Asthma severity in patients treated with fixed combination | 1 year | No | |
| Secondary | Strength/dose of prescribed fixed combination | 1 year | No |
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