Back to resultsStudy of MAP0010 in Asthmatic Children and Adolescents
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MAP0010 low dose
MAP0010 high dose
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Male or female asthmatic children/adolescents
- 1 to 18 years of age
- FEV1 greater than or equal to 50% predicted normal (where obtainable)
- Stable but symptomatic
- Diagnosis of asthma (per NIH criteria) at least 3 months before screening OR documented exacerbation or worsening of asthma or symptoms suggestive of asthma including nocturnal asthma, within 6 months of screening OR documented SAB use more than or at least once for symptom relief during the 4 days of run in with a total symptom score greater than or equal to 1 OR greater than or equal to 1 night disturbed due to asthma symptoms in previous month.
Exclusion Criteria:
- Any other significant childhood illness.
- Participated in any investigational clinical trial within the 30 days prior to screening.
- Use of any corticosteroid within 2 weeks of screening.
- Use of oral corticosteroid within 30 days of screening or prolonged use of oral corticosteroids within 12 weeks of screening.
- Use of inhaled long acting bronchodilators.
- Presumptive or documented history of upper or lower respiratory infection within 2 weeks before screening.
- Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
- History suggestive (or diagnosis) of other concomitant lung disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
MAP0010 low dose
MAP0010 high dose
Placebo
Arm Description
a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
Placebo delivered by nebulization twice daily for 6 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 5 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 5 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. An increase indicates an improvement (a greater volume of air expired).
Full Information
NCT ID
NCT00697801
First Posted
June 12, 2008
Last Updated
December 9, 2013
Sponsor
Allergan
Collaborators
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
1. Study Identification
Unique Protocol Identification Number
NCT00697801
Brief Title
Study of MAP0010 in Asthmatic Children and Adolescents
Official Title
A Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group, Phase 2 Study Investigating the Efficacy, Tolerability and Pharmacokinetics of MAP0010 in Asthmatic Children and Adolescents Over 6 Weeks
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (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 objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MAP0010 low dose
Arm Type
Experimental
Arm Description
a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
Arm Title
MAP0010 high dose
Arm Type
Experimental
Arm Description
a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo delivered by nebulization twice daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
MAP0010 low dose
Intervention Description
a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
MAP0010 high dose
Intervention Description
a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo delivered by nebulization twice daily for 6 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 5 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 6
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 5 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 6
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. An increase indicates an improvement (a greater volume of air expired).
Time Frame
baseline, week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female asthmatic children/adolescents
1 to 18 years of age
FEV1 greater than or equal to 50% predicted normal (where obtainable)
Stable but symptomatic
Diagnosis of asthma (per NIH criteria) at least 3 months before screening OR documented exacerbation or worsening of asthma or symptoms suggestive of asthma including nocturnal asthma, within 6 months of screening OR documented SAB use more than or at least once for symptom relief during the 4 days of run in with a total symptom score greater than or equal to 1 OR greater than or equal to 1 night disturbed due to asthma symptoms in previous month.
Exclusion Criteria:
Any other significant childhood illness.
Participated in any investigational clinical trial within the 30 days prior to screening.
Use of any corticosteroid within 2 weeks of screening.
Use of oral corticosteroid within 30 days of screening or prolonged use of oral corticosteroids within 12 weeks of screening.
Use of inhaled long acting bronchodilators.
Presumptive or documented history of upper or lower respiratory infection within 2 weeks before screening.
Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
History suggestive (or diagnosis) of other concomitant lung disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Official's Role
Study Director
Facility Information:
City
San Diego
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of MAP0010 in Asthmatic Children and Adolescents
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