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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00419952 |
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Date of registration:
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05/01/2007 |
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Primary sponsor: |
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Public title:
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A Comparison of SYMBICORT pMDI With Budesonide HFA pMDI in African American Subjects With Asthma.
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Scientific title:
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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 |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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720 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00419952 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Christer Hultquist, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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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
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Drug: Budesonide HFA pMDI
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Drug: Budesonide/formoterol (SYMBICORT) pMDI
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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)
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To collect a blood sample for pharmacogenetic analyses in all subjects
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Secondary ID(s)
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D5896C00022
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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