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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00651547 |
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Date of registration:
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01/04/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Symbicort in Asthmatic Children - SEEDLING
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Scientific title:
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A 12 Week Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of Symbicort TM (40/4.5 Mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Asthmatic Children Aged Six to Eleven Years - SEEDLING 40/4.5 |
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Date of first enrolment:
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July 2002 |
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Target sample size:
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405 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00651547 |
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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 (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Contacts
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Name:
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Catherine Bonuccelli |
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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:
- Baseline lung function tests results as determined by the protocol
- Required and received treatment with inhaled corticosteroids within the timeframe and
doses specified in the protocol
Exclusion Criteria:
- Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has
sensitivity to drugs specified in the protocol or requires treatment with
beta-blockers
- Has been hospitalised or required emergency treatment for asthma-related condition
within previous 6 months
- Has had cancer within previous 5 years or has a significant disease, as judged by
investigator, that may put the patient at risk in this study
Age minimum:
6 Years
Age maximum:
11 Years
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/formoterol
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Drug: formoterol
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Drug: budesonide
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Primary Outcome(s)
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Morning PEF
[Time Frame: Daily]
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Secondary Outcome(s)
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Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments
[Time Frame: Throughout the treatment period]
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Secondary ID(s)
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D5896C00718
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SD-039-0718
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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