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

July 22, 2011 updated by: AstraZeneca

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)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2815

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • 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, Czech Republic
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic (specialists in allergology and pulmology)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of packs of fixed combination prescribed to patients with asthma bronchiale in one year
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Asthma severity in patients treated with fixed combination
Time Frame: 1 year
1 year
Strength/dose of prescribed fixed combination
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Viktor Kasak, MD, LERYMED spol. s.r.o.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

March 30, 2011

First Posted (Estimate)

March 31, 2011

Study Record Updates

Last Update Posted (Estimate)

July 25, 2011

Last Update Submitted That Met QC Criteria

July 22, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-RCZ-SYM-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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