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A Comparison of SYMBICORT pMDI With Budesonide HFA pMDI in African American Subjects With Asthma.
This study is ongoing, but not recruiting participants.
First Received: January 5, 2007   Last Updated: November 12, 2009   History of Changes
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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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 Arformoterol Formoterol Symbicort 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

Estimated Enrollment: 720
Study Start Date: February 2007
Estimated Study Completion Date: December 2009
  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

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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: D5896C00022
Study First Received: January 5, 2007
Last Updated: November 12, 2009
ClinicalTrials.gov Identifier: NCT00419952     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 27, 2009



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