A Study of 2 Doses of MAP0010 in Asthmatic Children
Primary Purpose
Asthma
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
0.135mg MAP0010
0.25mg MAP0010
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring asthmatic children
Eligibility Criteria
Inclusion Criteria:
- Completed 12 weeks of treatment in the MAP0010-CL-P301 study.
- Patient, parent, and guardian (as appropriate) are willing for child to undergo all study procedures and willing to sign the informed consent and assent, as appropriate.
Exclusion Criteria:
- Less than 80% compliance with either study treatment and/or other study procedures (e.g., completion of symptom e-diary) in the MAP0010-CL-P301 Study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
0.135mg MAP0010
0.25mg MAP0010
Arm Description
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
Outcomes
Primary Outcome Measures
Number of Patients With Treatment Emergent Adverse Events Related to Study Drug
A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.
Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination
A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.
Secondary Outcome Measures
Full Information
NCT ID
NCT00697697
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
NCT00697697
Brief Title
A Study of 2 Doses of MAP0010 in Asthmatic Children
Official Title
A Randomized, Double-blind, Active-controlled, Phase 3 Extension Study Investigating the Safety and Efficacy Over 40 Weeks of 2 Doses of MAP0010 in Asthmatic Children (12 Months to 8 Years Old at the Time of Enrollment Into the MAP0010-CL-P301 Study)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
Corporate decision
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
December 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 of two doses of MAP0010 in asthmatic children, 12 months to 8 years of age, over a 40-week 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
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.135mg MAP0010
Arm Type
Experimental
Arm Description
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
Arm Title
0.25mg MAP0010
Arm Type
Experimental
Arm Description
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
Intervention Type
Drug
Intervention Name(s)
0.135mg MAP0010
Intervention Description
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
Intervention Type
Drug
Intervention Name(s)
0.25mg MAP0010
Intervention Description
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
Primary Outcome Measure Information:
Title
Number of Patients With Treatment Emergent Adverse Events Related to Study Drug
Description
A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.
Time Frame
40 weeks
Title
Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination
Description
A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.
Time Frame
40 weeks
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:
Completed 12 weeks of treatment in the MAP0010-CL-P301 study.
Patient, parent, and guardian (as appropriate) are willing for child to undergo all study procedures and willing to sign the informed consent and assent, as appropriate.
Exclusion Criteria:
Less than 80% compliance with either study treatment and/or other study procedures (e.g., completion of symptom e-diary) in the MAP0010-CL-P301 Study.
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 in Asthmatic Children
We'll reach out to this number within 24 hrs