Symbicort in Asthmatic Children - SEEDLING

March 27, 2009 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

405

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: budesonide/formoterol
Other Names:
  • Symbicort
Active Comparator: 2
Drug: budesonide
Active Comparator: 3
Drug: formoterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morning PEF
Time Frame: Daily
Daily

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Catherine Bonuccelli, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimate)

April 3, 2008

Study Record Updates

Last Update Posted (Estimate)

March 30, 2009

Last Update Submitted That Met QC Criteria

March 27, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SD-039-0718
  • D5896C00718

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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