Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients (UFO)
| Tracking Information | |||||
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| First Received Date ICMJE | March 28, 2011 | ||||
| Last Updated Date | July 22, 2011 | ||||
| Start Date ICMJE | April 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Number of packs of fixed combination prescribed to patients with asthma bronchiale in one year [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Number of packs of fixed combination prescsribed to patients with asthma bronchiale in one year [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01327001 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients | ||||
| Official Title ICMJE | 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) | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Primary care clinic (specialists in allergology and pulmology) |
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| Condition ICMJE | Asthma | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 2815 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Czech Republic | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01327001 | ||||
| Other Study ID Numbers ICMJE | NIS-RCZ-SYM-2010/1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | MC MD, AstraZeneca | ||||
| Study Sponsor ICMJE | AstraZeneca | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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