Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients (UFO)
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Purpose
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.
| Condition |
|---|
|
Asthma |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| 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) |
- Number of packs of fixed combination prescribed to patients with asthma bronchiale in one year [ 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 of prescribed fixed combination [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 2815 |
| Study Start Date: | April 2011 |
| Study Completion Date: | June 2011 |
Eligibility| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Primary care clinic (specialists in allergology and pulmology)
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
Contacts and Locations
Show 100 Study Locations| Principal Investigator: | Viktor Kasak, MD | LERYMED spol. s.r.o. |
More Information
No publications provided
| Responsible Party: | MC MD, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01327001 History of Changes |
| Other Study ID Numbers: | NIS-RCZ-SYM-2010/1 |
| Study First Received: | March 28, 2011 |
| Last Updated: | July 22, 2011 |
| Health Authority: | Czech Republic: State Institute for Drug Control |
Keywords provided by AstraZeneca:
|
Asthma bronchiale, fixed combination |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Beclomethasone Budesonide Formoterol Salmeterol Symbicort |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
ClinicalTrials.gov processed this record on June 18, 2013