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Long-Term Safety of Symbicort in Asthmatic Children - SAPLING

NCT ID: NCT00646529

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

175 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 assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years

Detailed Description

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Conditions

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Asthma

Keywords

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asthma children Symbicort budesonide/formoterol Pulmicort budesonide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

budesonide/formoterol

Group Type EXPERIMENTAL

budesonide/formoterol (Symbicort)

Intervention Type DRUG

2

budesonide

Group Type ACTIVE_COMPARATOR

budesonide (Pulmicort)

Intervention Type DRUG

Interventions

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budesonide/formoterol (Symbicort)

Intervention Type DRUG

budesonide (Pulmicort)

Intervention Type DRUG

Other Intervention Names

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Symbicort Pulmicort

Eligibility Criteria

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Inclusion Criteria

* At least 6 and maximally 11 years of age
* Diagnosis of asthma
* Baseline lung function tests as determined by protocol and required and received daily treatment with inhaled corticosteroids for at least 4 weeks prior to study start

Exclusion Criteria

* Has required treatment with any non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
* Has had cancer in the previous 5 years or has a significant disease 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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D5896C00719

Identifier Type: -

Identifier Source: secondary_id

SD-039-0719

Identifier Type: -

Identifier Source: org_study_id