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
  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)

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

Primary care clinic (specialists in allergology and pulmology)

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327001

  Show 100 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
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 August 01, 2014