A Comparison of SYMBICORT pMDI With Budesonide HFA pMDI in African American Subjects With Asthma. - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00419952

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 African American population.

Condition	Intervention	Phase
Asthma	Drug: Budesonide/formoterol (SYMBICORT) pMDI Drug: Budesonide HFA pMDI	Phase 3

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 52-week, Randomised, Double-blind, Parallel-group, Multi-centre, Phase IIIB Study Comparing the Long Term Safety of SYMBICORTÒ pMDI 160/4.5 mg x 2 Actuations Twice Daily to Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily in Adult/Adolescent (≥12 Years) African American Subjects With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Formoterol Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the long-term safety profile of SYMBICORT pMDI 160/4.5 μg x 2 actuations twice daily compared to budesonide HFA pMDI 160 μg x 2 actuations twice daily, in African American subjects with moderate to severe asthma, over a 52-week treatment perio

Secondary Outcome Measures:

Patient reported outcome variables over a 52-week treatment period collected using Onset of Effect Questionnaire to assess pre-dose FEV1 and morning peak expiratory flow (AM PEF)
To collect a blood sample for pharmacogenetic analyses in all subjects

Enrollment:	720
Study Start Date:	February 2007
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Male or Female, African American (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: NCT00419952

Show 122 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

ClinicalTrials.gov Identifier:	NCT00419952 History of Changes
Other Study ID Numbers:	D5896C00022
Study First Received:	January 5, 2007
Last Updated:	April 23, 2010
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 May 22, 2012