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Symbicort in Asthmatic Children - SEEDLING

NCT ID: NCT00651547

Last Updated: 2009-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2003-10-31

Brief Summary

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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

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Conditions

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Asthma

Keywords

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Asthma Symbicort budesonide/formoterol budesonide formoterol children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type EXPERIMENTAL

budesonide/formoterol

Intervention Type DRUG

2

Group Type ACTIVE_COMPARATOR

budesonide

Intervention Type DRUG

3

Group Type ACTIVE_COMPARATOR

formoterol

Intervention Type DRUG

Interventions

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budesonide/formoterol

Intervention Type DRUG

budesonide

Intervention Type DRUG

formoterol

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility 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
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Catherine Bonuccelli

Role: STUDY_DIRECTOR

AstraZeneca

Other Identifiers

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D5896C00718

Identifier Type: -

Identifier Source: secondary_id

SD-039-0718

Identifier Type: -

Identifier Source: org_study_id