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

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

MedlinePlus related topics:

Asthma

Drug Information available for:

Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Budesonide Symbicort

U.S. FDA Resources

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

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
Estimated 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

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	D5896C00021
First Received:	January 5, 2007
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00419757
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Moderate asthma

Severe asthma

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Symbicort

Respiratory Tract Diseases

Lung Diseases

Budesonide

Hypersensitivity, Immediate

Formoterol

Asthma

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Bronchial Diseases

Immune System Diseases

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents

Glucocorticoids

Hormones

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on November 20, 2008

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