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A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
0.135mg MAP0010
0.25mg MAP0010
Placebo
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:

  • Male or female asthmatic children with mild to moderate persistent asthma.
  • 12 months to 8 years of age.
  • For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.
  • For infants age 12 to <48 months old: 2 or more wheezing episodes in past 12 months which lasted > 1 day and affected sleep.
  • AND with at least one major or two minor risk factors.

Exclusion Criteria:

  • Any other significant childhood illness/abnormality or chronic lung disease
  • Any history of upper or lower respiratory tract infection, within 2 weeks of screening.
  • Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
  • Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.
  • Any use of oral corticosteroids within 30 days of screening or prolonged use (>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Arm Label

    0.25mg MAP0010

    Placebo

    0.135mg MAP0010

    Arm Description

    0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

    Placebo delivered by nebulization twice daily for 12 weeks

    0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Daytime Composite Symptom Score
    The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 7 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.
    Change From Baseline in Nighttime Composite Symptom Score
    The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 7 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.

    Secondary Outcome Measures

    Change From Baseline in FEV1% Predicted
    The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer and the largest volume from the 3 maneuvers was selected. An increase indicates an improvement (a greater volume of air expired).
    Change From Baseline in PEF
    The peak expiratory flow (PEF) is the highest air flow achieved from a maximum forced expiratory maneuver measured in liters of air per minute (L/min). Subjects had to perform at least 3 acceptable maneuvers into a PEF meter. An increase indicates an improvement (a greater volume of air expired).
    Change From Baseline in Daytime Individual Symptom Scores
    The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Individual Daytime symptom score is defined as an average of the last 5 days' individual symptom scores within the last 7 days immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.
    Change From Baseline in Nighttime Individual Symptom Scores
    The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Individual nighttime symptom score is defined as an average of the last 5 nights' individual symptom scores within the last 7 nights immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.

    Full Information

    First Posted
    December 5, 2007
    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
    NCT00569192
    Brief Title
    A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children
    Official Title
    A Randomized, Double Blind, Placebo Controlled, Parallel Group, Study Investigating the Safety and Efficacy Over 12 Weeks Treatment Period of MAP0010 in Asthmatic Infants and Children 12 Months to 8 Years of Age
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2007 (undefined)
    Primary Completion Date
    September 2008 (Actual)
    Study Completion Date
    January 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 and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment 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
    360 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    0.25mg MAP0010
    Arm Type
    Experimental
    Arm Description
    0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo delivered by nebulization twice daily for 12 weeks
    Arm Title
    0.135mg MAP0010
    Arm Type
    Experimental
    Arm Description
    0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    0.135mg MAP0010
    Intervention Description
    0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    0.25mg MAP0010
    Intervention Description
    0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo delivered by nebulization twice daily for 12 weeks
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Daytime Composite Symptom Score
    Description
    The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 7 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.
    Time Frame
    baseline, week 12
    Title
    Change From Baseline in Nighttime Composite Symptom Score
    Description
    The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 7 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.
    Time Frame
    baseline, week 12
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in FEV1% Predicted
    Description
    The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer and the largest volume from the 3 maneuvers was selected. An increase indicates an improvement (a greater volume of air expired).
    Time Frame
    baseline, week 12
    Title
    Change From Baseline in PEF
    Description
    The peak expiratory flow (PEF) is the highest air flow achieved from a maximum forced expiratory maneuver measured in liters of air per minute (L/min). Subjects had to perform at least 3 acceptable maneuvers into a PEF meter. An increase indicates an improvement (a greater volume of air expired).
    Time Frame
    baseline, week 12
    Title
    Change From Baseline in Daytime Individual Symptom Scores
    Description
    The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Individual Daytime symptom score is defined as an average of the last 5 days' individual symptom scores within the last 7 days immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.
    Time Frame
    baseline, week 12
    Title
    Change From Baseline in Nighttime Individual Symptom Scores
    Description
    The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Individual nighttime symptom score is defined as an average of the last 5 nights' individual symptom scores within the last 7 nights immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.
    Time Frame
    baseline, week 12

    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: Male or female asthmatic children with mild to moderate persistent asthma. 12 months to 8 years of age. For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria. For infants age 12 to <48 months old: 2 or more wheezing episodes in past 12 months which lasted > 1 day and affected sleep. AND with at least one major or two minor risk factors. Exclusion Criteria: Any other significant childhood illness/abnormality or chronic lung disease Any history of upper or lower respiratory tract infection, within 2 weeks of screening. Any history of acute or severe asthma attack requiring ICU admission or ventilatory support. Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening. Any use of oral corticosteroids within 30 days of screening or prolonged use (>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.
    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 and Placebo in Asthmatic Children

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