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Symbicort in Asthmatic Children - SEEDLING

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
budesonide/formoterol
budesonide
formoterol
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Symbicort, budesonide/formoterol, budesonide, formoterol, children

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    Outcomes

    Primary Outcome Measures

    Morning PEF

    Secondary Outcome Measures

    Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments

    Full Information

    First Posted
    April 1, 2008
    Last Updated
    March 27, 2009
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00651547
    Brief Title
    Symbicort in Asthmatic Children - SEEDLING
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    Asthma, Symbicort, budesonide/formoterol, budesonide, formoterol, children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    405 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Title
    3
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    budesonide/formoterol
    Other Intervention Name(s)
    Symbicort
    Intervention Type
    Drug
    Intervention Name(s)
    budesonide
    Intervention Type
    Drug
    Intervention Name(s)
    formoterol
    Primary Outcome Measure Information:
    Title
    Morning PEF
    Time Frame
    Daily
    Secondary Outcome Measure Information:
    Title
    Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments
    Time Frame
    Throughout the treatment period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Catherine Bonuccelli
    Organizational Affiliation
    AstraZeneca
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Symbicort in Asthmatic Children - SEEDLING

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