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A Study of 2 Doses of MAP0010 in Asthmatic Children

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
0.135mg MAP0010
0.25mg MAP0010
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthmatic children

Eligibility Criteria

12 Months - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Completed 12 weeks of treatment in the MAP0010-CL-P301 study.
  • Patient, parent, and guardian (as appropriate) are willing for child to undergo all study procedures and willing to sign the informed consent and assent, as appropriate.

Exclusion Criteria:

  • Less than 80% compliance with either study treatment and/or other study procedures (e.g., completion of symptom e-diary) in the MAP0010-CL-P301 Study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    0.135mg MAP0010

    0.25mg MAP0010

    Arm Description

    0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks

    0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks

    Outcomes

    Primary Outcome Measures

    Number of Patients With Treatment Emergent Adverse Events Related to Study Drug
    A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.
    Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination
    A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 12, 2008
    Last Updated
    December 9, 2013
    Sponsor
    Allergan
    Collaborators
    MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00697697
    Brief Title
    A Study of 2 Doses of MAP0010 in Asthmatic Children
    Official Title
    A Randomized, Double-blind, Active-controlled, Phase 3 Extension Study Investigating the Safety and Efficacy Over 40 Weeks of 2 Doses of MAP0010 in Asthmatic Children (12 Months to 8 Years Old at the Time of Enrollment Into the MAP0010-CL-P301 Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Terminated
    Why Stopped
    Corporate decision
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    December 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Allergan
    Collaborators
    MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to examine the safety of two doses of MAP0010 in asthmatic children, 12 months to 8 years of age, over a 40-week period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    asthmatic children

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    0.135mg MAP0010
    Arm Type
    Experimental
    Arm Description
    0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
    Arm Title
    0.25mg MAP0010
    Arm Type
    Experimental
    Arm Description
    0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    0.135mg MAP0010
    Intervention Description
    0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    0.25mg MAP0010
    Intervention Description
    0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
    Primary Outcome Measure Information:
    Title
    Number of Patients With Treatment Emergent Adverse Events Related to Study Drug
    Description
    A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.
    Time Frame
    40 weeks
    Title
    Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination
    Description
    A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.
    Time Frame
    40 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Completed 12 weeks of treatment in the MAP0010-CL-P301 study. Patient, parent, and guardian (as appropriate) are willing for child to undergo all study procedures and willing to sign the informed consent and assent, as appropriate. Exclusion Criteria: Less than 80% compliance with either study treatment and/or other study procedures (e.g., completion of symptom e-diary) in the MAP0010-CL-P301 Study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    MAP Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of 2 Doses of MAP0010 in Asthmatic Children

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