An Efficacy Study Comparing SYMBICORT® pMDI With Budesonide HFA pMDI, in Hispanic Subjects With ICS Dependent Asthma - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00419757

Purpose

The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the Hispanic population.

Condition	Intervention	Phase
Asthma	Drug: Budesonide/formoterol (SYMBICORT) pMDI Drug: Budesonide HFA pMDI	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre, Phase IIIB Study Comparing the Efficacy and Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily Versus Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily, in Adult/Adolescent (> 12 Yrs) Hispanic Subjects With Asthma

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 compare the efficacy of SYMBICORT pMDI 160/4.5 mg x 2 actuations bid to that of budesonide HFA pMDI 160 mg x 2 actuations bid, in Hispanic subjects with ICS dependent asthma.
The primary efficacy variable will be morning Peak Expiratory Flow (AM PEF)

Secondary Outcome Measures:

To evaluate the safety of SYMBICORT pMDI compared to budesonide.
To collect a peripheral blood sample for pharmacogenetic testing in consenting subjects for future pharmacogenetic analyses to be conducted outside the scope of the clinical study report

Estimated Enrollment:	240
Study Start Date:	January 2007
Study Completion Date:	June 2008

Eligibility

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

Criteria

Inclusion Criteria:

Male or Female, Hispanic (self-reported), > 12 years of age
Moderate to severe asthma requiring treatment with an inhaled corticosteroid
Diagnosis of asthma for at least 6 months

Exclusion Criteria:

Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
Any significant disease or disorder that may jeopardize a subject's safety

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419757

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Locations

United States, California
Research Site
Anaheim, California, United States
Research Site
Chula Vista, California, United States
Research Site
Fresno, California, United States
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Fullerton, California, United States
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Riverside, California, United States
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National City, California, United States
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Rancho Cordova, California, United States
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Rancho Mirage, California, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Stockton, California, United States
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Torrance, California, United States
United States, Colorado
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Pueblo, Colorado, United States
United States, Florida
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Largo, Florida, United States
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Miami, Florida, United States
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Naranja, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Panama City, Florida, United States
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South Miami, Florida, United States
United States, Illinois
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Chicago, Illinois, United States
United States, New York
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Newburgh, New York, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States
United States, Texas
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Boerne, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Spring, Texas, United States
Puerto Rico
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Aguas Buenas, Puerto Rico
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Caquas, Puerto Rico
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Trujillo Alto, Puerto Rico
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Levittown, Puerto Rico
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Ponce, Puerto Rico
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SanJuan, Puerto Rico
Research Site
Cidra, Puerto Rico

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Christer Hultquist, MD

AstraZeneca

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	D5896C00021
Study First Received:	January 5, 2007
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00419757 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Moderate asthma
Severe asthma

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 25, 2009