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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01327001
Recruitment Status : Completed
First Posted : March 31, 2011
Last Update Posted : July 25, 2011
Information provided by:

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.

Condition or disease

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Study Type : Observational
Actual Enrollment : 2815 participants
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)
Study Start Date : April 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Salmeterol

Primary Outcome Measures :
  1. Number of packs of fixed combination prescribed to patients with asthma bronchiale in one year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Asthma severity in patients treated with fixed combination [ Time Frame: 1 year ]
  2. Strength/dose of prescribed fixed combination [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01327001

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Sponsors and Collaborators
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Principal Investigator: Viktor Kasak, MD LERYMED spol. s.r.o.

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Responsible Party: MC MD, AstraZeneca Identifier: NCT01327001    
Other Study ID Numbers: NIS-RCZ-SYM-2010/1
First Posted: March 31, 2011    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011
Keywords provided by AstraZeneca:
Asthma bronchiale, fixed combination
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents