Long-Term Safety of Symbicort in Asthmatic Children - SAPLING

March 27, 2009 updated by: AstraZeneca

A Six Month, Randomized, Open-Label, Safety Study of Symbicort (160/4.5mcg) Compared to Pulmicort Turbuhaler in Asthmatic Children Aged Six to Eleven Years - SAPLING

The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

175

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

4 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Long term safety profile of Symbicort compared to Pulmicort as determined by safety assessments detailed in the protocol
Time Frame: 4 assessments within 26 week treatment period
4 assessments within 26 week treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare health economic outcomes and quality of life between patients treated with Symbicort and Pulmicort
Time Frame: 4 assessments within 26 week treatment period
4 assessments within 26 week 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

March 26, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (Estimate)

March 28, 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-039-0719
  • D5896C00719

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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