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Completed

NCT Number: NCT00569192

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 month–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.135mg MAP0010

Drug

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

0.25mg MAP0010

Drug

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

Placebo

Drug

Placebo delivered by nebulization twice daily for 12 weeks

Primary outcomes

  1. Change From Baseline in Daytime Composite Symptom Score

    Time frame: baseline, week 12

    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.

  2. Change From Baseline in Nighttime Composite Symptom Score

    Time frame: baseline, week 12

    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 outcomes

  1. Change From Baseline in FEV1% Predicted

    Time frame: baseline, week 12

    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).

  2. Change From Baseline in PEF

    Time frame: baseline, week 12

    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).

  3. Change From Baseline in Daytime Individual Symptom Scores

    Time frame: baseline, week 12

    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.

  4. Change From Baseline in Nighttime Individual Symptom Scores

    Time frame: baseline, week 12

    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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Collaborators

  • MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Dec 7, 2007
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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