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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Show 39 Study Locations

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 by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zangrilli J, Mansfield LE, Uryniak T, O'Brien CD. Efficacy of budesonide/formoterol pressurized metered-dose inhaler versus budesonide pressurized metered-dose inhaler alone in Hispanic adults and adolescents with asthma: a randomized, controlled trial. Ann Allergy Asthma Immunol. 2011 Sep;107(3):258-65.e2. Epub 2011 Jul 14.

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

Keywords provided by AstraZeneca:

Moderate asthma
Severe asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012