Study Stopped
Corporate decision
A Study of 2 Doses of MAP0010 in Asthmatic Children
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)
1 other identifier
interventional
192
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Apr 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 12, 2008
CompletedFirst Posted
Study publicly available on registry
June 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
October 23, 2013
CompletedJanuary 9, 2014
December 1, 2013
1.3 years
June 12, 2008
August 19, 2013
December 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
40 weeks
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.
40 weeks
Study Arms (2)
0.135mg MAP0010
EXPERIMENTAL0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
0.25mg MAP0010
EXPERIMENTAL0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated due to a corporate decision before all subjects had completed the study.
Results Point of Contact
- Title
- VP, Scientific Affairs
- Organization
- MAP Pharmaceuticals, Inc. a wholly owned subsidiary of Allergan
Study Officials
- STUDY DIRECTOR
Medical Director
MAP Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2008
First Posted
June 16, 2008
Study Start
April 1, 2008
Primary Completion
August 1, 2009
Study Completion
December 1, 2009
Last Updated
January 9, 2014
Results First Posted
October 23, 2013
Record last verified: 2013-12