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NCT00651547 Clinical Trial

Symbicort in Asthmatic Children - SEEDLING

Asthma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00651547
Other study ID # SD-039-0718
Secondary ID D5896C00718
Status Completed
Phase Phase 3
First received April 1, 2008
Last updated March 27, 2009
Start date July 2002
Est. completion date October 2003

Study information
Verified date March 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11 years

Recruitment information / eligibility
Status Completed
Enrollment 405
Est. completion date October 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 11 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• budesonide/formoterol

• budesonide

• formoterol

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Outcome
Type Measure Description Time frame Safety issue
Primary Morning PEF Daily
Secondary Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments Throughout the treatment period
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