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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01327001
First received: March 28, 2011
Last updated: July 22, 2011
Last verified: July 2011

March 28, 2011
July 22, 2011
April 2011
Not Provided
Number of packs of fixed combination prescribed to patients with asthma bronchiale in one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number of packs of fixed combination prescsribed to patients with asthma bronchiale in one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01327001 on ClinicalTrials.gov Archive Site
  • Asthma severity in patients treated with fixed combination [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Strength/dose of prescribed fixed combination [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Asthma severity in patients treated with fixed combination [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Strength/dose ofprescribed fixed combination [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

Primary care clinic (specialists in allergology and pulmology)

Asthma
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2815
June 2011
Not Provided

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
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01327001
NIS-RCZ-SYM-2010/1
No
MC MD, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Viktor Kasak, MD LERYMED spol. s.r.o.
AstraZeneca
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP