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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 19, 2014