Symbicort Rapihaler Therapeutic Equivalence Study - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00536731

Purpose

The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.

Condition	Intervention	Phase
Bronchial Asthma	Drug: Symbicort Turbuhaler Drug: Symbicort pMDI Drug: Pulmicort Turbuhaler	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A 6-Week, Phase III, Double-Blind, Randomized, Multi-Centre, Parallel-Group Study Evaluating the Efficacy and Safety of 2 Actuations Symbicort®pMDI® 40/2.25 μg Twice Daily Compared With 1 Inhalation Symbicort Turbuhaler® 80/4.5 μg Twice Daily and 1 Inhalation Pulmicort®Turbuhaler® 100 μg Twice Daily

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide Symbicort

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary objective is to show that Symbicort pMDI 40/2.25 μg two actuations b.i.d is more efficacious than Pulmicort Turbuhaler 100 μg one inhalation b.i.d. over a 6-week treatment period.

Secondary Outcome Measures:

Secondary objectives are to compare the efficacy of Symbicort pMDI 40/2.25 μg two actuations b.i.d with that of Symbicort Turbuhaler 80/4.5 μg one inhalation b.i.d and to investigate the safety profile of Symbicort pMDI 40/2.25 μg two actuations b.i.d,

Estimated Enrollment:	600
Study Start Date:	September 2007
Study Completion Date:	April 2008

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

· · Asthma clinically diagnosed since at least 6 months.
Lung function values measured ≥ 50% and ≤ 90% of predicted normal.
Patients with reversible airway obstruction Daily use of inhaled steroids (any brand) for >3 months.

Exclusion Criteria:

· Use of oral, rectal or parenteral steroids within 30 days prior to start of study.
Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to start of randomised treatment.

Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536731

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Locations

Bulgaria
Research Site
PLEVEN, Bulgaria
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PLOVDIV, Bulgaria
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RUSE, Bulgaria
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VARNA, Bulgaria
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SOFIA, Bulgaria
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RUSSE, Bulgaria
Czech Republic
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KUTNA HORA, Czech Republic
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HRADEC KRALOVE, Czech Republic
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JIHLAVA, Czech Republic
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KLADNO, Czech Republic
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KOLIN 4, Czech Republic
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BENESOV U PRAHY, Czech Republic
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LITOMERICE, Czech Republic
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NERATOVICE, Czech Republic
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PARDUBICE, Czech Republic
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PRAHA 4, Czech Republic
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ROKYCANY, Czech Republic
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PRAHA 8, Czech Republic
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PRAHA 5, Czech Republic
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STRAKONICE, Czech Republic
Hungary
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BALASSAGYARMAT, Hungary
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BUDAPEST, Hungary
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CEGL�D, Hungary
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DEBRECEN, Hungary
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DESZK, Hungary
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GY?R, Hungary
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GYULA, Hungary
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KAPOSV�R, Hungary
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NY�REGYH�ZA, Hungary
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T�R�KB�LINT, Hungary
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SZ�ZHALOMBATTA, Hungary
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SZEGED, Hungary
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SZARVAS, Hungary
Poland
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BIA?YSTOK, Poland
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BIELSKO-BIA?A, Poland
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BYDGOSZCZ, Poland
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CHODZIE?, Poland
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CHRZAN�W, Poland
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WROC?AW, Poland
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KRAK�W, Poland
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LUBLIN, Poland
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?�D?, Poland
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?OM?A, Poland
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OSTR�W WIELKOPOLSKI, Poland
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POZNA?, Poland
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SKIERNIEWICE, Poland
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SZCZECIN, Poland
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TARN�W, Poland
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TUREK, Poland
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WODZIS?AW ?L?SKI, Poland
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KARPACZ, Poland

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Tomas Andersson	AstraZeneca
Principal Investigator:	Akos Somoskovi	AstraZeneca

More Information

No publications provided

Study ID Numbers:	D5897C00003
Study First Received:	September 27, 2007
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00536731 History of Changes
Health Authority:	Hungary: National Institute of Pharmacy (OGYI); Poland: Office for Registration of Medicinal Products; Czech Republic: State Institute for Drug Control; Bulgaria: Bulgarian Drug Agency (BDA)

Keywords provided by AstraZeneca:

Asthma
Symbicort

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Symbicort
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Asthma
Hormones
Glucocorticoids

Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 27, 2009