Symbicort in Asthmatic Children - SEEDLING - Tabular View

Tracking Information

First Received Date ^ICMJE

April 1, 2008

Last Updated Date

March 27, 2009

Start Date ^ICMJE

July 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Morning PEF [ Time Frame: Daily ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00651547 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments [ Time Frame: Throughout the treatment period ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Symbicort in Asthmatic Children - SEEDLING

Official Title ^ICMJE

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

Brief 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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: budesonide/formoterol
Drug: budesonide
Drug: formoterol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

405

Completion Date

October 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 11 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00651547

Responsible Party

Study ID Numbers ^ICMJE

SD-039-0718, D5896C00718

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Catherine Bonuccelli

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP