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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.
Information provided by:
AstraZeneca Identifier:
First received: March 28, 2011
Last updated: July 22, 2011
Last verified: July 2011

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 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)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

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

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

Enrollment: 2815
Study Start Date: April 2011
Study Completion Date: June 2011

Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01327001

  Show 100 Study Locations
Sponsors and Collaborators
Principal Investigator: Viktor Kasak, MD LERYMED spol. s.r.o.
  More Information

Responsible Party: MC MD, AstraZeneca 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

Keywords provided by AstraZeneca:
Asthma bronchiale, fixed combination

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Salmeterol Xinafoate
Budesonide, Formoterol Fumarate Drug Combination
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
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017