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

This study has been completed.
Sponsor:
Collaborator:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00569192
First received: December 5, 2007
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: 0.135mg MAP0010
Drug: 0.25mg MAP0010
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Daytime Composite Symptom Score [ Time Frame: baseline, week 12 ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: baseline, week 12 ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: baseline, week 12 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: baseline, week 12 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: baseline, week 12 ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: baseline, week 12 ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 360
Study Start Date: December 2007
Study Completion Date: January 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.25mg MAP0010
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
Drug: 0.25mg MAP0010
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
Placebo Comparator: Placebo
Placebo delivered by nebulization twice daily for 12 weeks
Drug: Placebo
Placebo delivered by nebulization twice daily for 12 weeks
Experimental: 0.135mg MAP0010
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
Drug: 0.135mg MAP0010
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

  Eligibility

Ages Eligible for Study:   12 Months to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569192

Sponsors and Collaborators
Allergan
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Investigators
Study Director: Medical Director MAP Pharmaceuticals
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00569192     History of Changes
Other Study ID Numbers: MAP0010-CL-P301
Study First Received: December 5, 2007
Results First Received: August 19, 2013
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Allergan:
asthmatic children

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 22, 2014