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Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
budesonide/formoterol
budesonide and placebo
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, adolescents, adults, Symbicort, budesonide/formoterol, budesonide

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of asthma and baseline lung function tests as determined by the protocol
  • Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

  • Severe asthma
  • Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in evening PEF

    Secondary Outcome Measures

    Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes
    Health-related quality of life
    Routine safety assessments

    Full Information

    First Posted
    April 1, 2008
    Last Updated
    January 21, 2011
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00652392
    Brief Title
    Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM
    Official Title
    A 12 Week, Randomized, Double-Blind, Double-Dummy, Placebo and Active-controlled Study of Symbicort pMDI Administered Once Daily in Adults and Adolescents With Asthma - STEM
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2004 (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 a dose of Symbicort taken once daily with other dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in adolescents and adults

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    budesonide/formoterol
    Other Intervention Name(s)
    Symbicort
    Intervention Type
    Drug
    Intervention Name(s)
    budesonide and placebo
    Primary Outcome Measure Information:
    Title
    Change in evening PEF
    Time Frame
    Daily throughout the 12 week treatment period
    Secondary Outcome Measure Information:
    Title
    Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes
    Time Frame
    Daily throughout the 12 week treatment period
    Title
    Health-related quality of life
    Time Frame
    4 assessments within 12 week treatment period
    Title
    Routine safety assessments
    Time Frame
    4 assessments within 12 week treatment period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of asthma and baseline lung function tests as determined by the protocol Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol Exclusion Criteria: Severe asthma Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Catherine Bonuccelli
    Organizational Affiliation
    AstraZeneca
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20167145
    Citation
    Berger WE, Bleecker ER, O'Dowd L, Miller CJ, Mezzanotte W. Efficacy and safety of budesonide/formoterol pressurized metered-dose inhaler: randomized controlled trial comparing once- and twice-daily dosing in patients with asthma. Allergy Asthma Proc. 2010 Jan-Feb;31(1):49-59. doi: 10.2500/aap.2010.31.3309.
    Results Reference
    derived

    Learn more about this trial

    Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM

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