Evaluating the Symbicort Turbuhaler (Formoterol/Budesonide) Maintenance and Reliever Therapy for Asthma in Daily Practice - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00782314

Purpose

We want to evaluate efficacy of Symbicort® Turbuhaler® (formoterol/budesonide) therapy for asthma in real life conditions. For this purpose we will include both patients that are treated with Symbicort® Turbuhaler® the "classical" maintenance only treatment approach as well as those treated with the SMART approach.

Condition
Asthma

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Evaluating the Symbicort Turbuhaler (Formoterol/Budesonide) Maintenance and Reliever Therapy for Asthma in Daily Practice

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

to determine the efficacy of both possible treatment approaches with Symbicort® Turbuhaler®, measured by asthma control [ Time Frame: three times: 0, 3, 6 months after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

to determine the number of maintenance and reliever inhalations of Symbicort® Turbuhaler®, as well as the concomitant usage of a separate reliever inhaler even in the case of SMART treatment approach [ Time Frame: three times: 0, 3, 6 months after inclusion ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	400
Study Start Date:	April 2008
Study Completion Date:	April 2009

Groups/Cohorts
1 patients with maintenance only treatment with Symbicort Turbuhaler for at least 1 month
2 patients with SMART treatment with Symbicort Turbuhaler for at least 1 month

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patients visiting pulmologist's office

Criteria

Inclusion Criteria:

patients diagnosed with persistent asthma treated with Symbicort® Turbuhaler® in line with its label
non-pregnant females
existing maintenance only treatment with Symbicort® Turbuhaler® 80 μg/4,5 μg, 160 μg/4,5 μg or 320 μg/9 μg for at least 1 month
existing SMART treatment with Symbicort® Turbuhaler® 80 μg/4,5 μg or 160 μg /4,5 μg for at least 1 month

Exclusion Criteria:

patients not being treated with Symbicort® Turbuhaler®
patients treated with Symbicort® Turbuhaler® for COPD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782314

Locations

Slovenia
Research Site
Celje, Slovenia
Research Site
Domzale, Slovenia
Research Site
Dvorec Sela, Slovenia
Research Site
Grosuplje, Slovenia
Research Site
Idrija, Slovenia
Research Site
Izola, Slovenia
Research Site
Jesenice, Slovenia
Research Site
Kamnik-Duplica, Slovenia
Research Site
Kranj, Slovenia
Research Site
Litija, Slovenia
Research Site
Ljubljana, Slovenia
Research Site
Lucija, Slovenia
Research Site
Zagorje, Slovenia
Research Site
Murska Sobota, Slovenia
Research Site
Novo mesto, Slovenia
Research Site
Ptuja, Slovenia
Research Site
Ravne na Koroskem, Slovenia
Research Site
Sezana, Slovenia
Research Site
Slovenj Gradec, Slovenia
Research Site
Slovenska Bistrica, Slovenia
Research Site
Topolsica, Slovenia
Research Site
Velenje, Slovenia
Research Site
Vrhnika, Slovenia
Research Site
Maribor, Slovenia

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Igor Koren, MD, MSc

Radix - medicinske storitve, Igor Koren s.p.

More Information

No publications provided

Responsible Party:	AstraZeneca UK Limited, Branch Office in Slovenia ( Meta Jeras, Mr Ph, Regulatory and Medical Affairs Manager )
Study ID Numbers:	NIS-RSI-SYM-2008/1
Study First Received:	October 29, 2008
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00782314 History of Changes
Health Authority:	Slovenia: Agency for Medicinal Products - Ministry of Health

Keywords provided by AstraZeneca:

asthma
SMART
Symbicort Turbuhaler
asthma control

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Symbicort
Bronchial Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses

Formoterol
Immune System Diseases
Adrenergic beta-Agonists
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 27, 2009