A Study of 2 Doses of MAP0010 in Asthmatic Children

Phase 3

Terminated

• Conditions: Asthma
• Interventions: Drug: 0.135mg MAP0010; Drug: 0.25mg MAP0010

• Registration Number: NCT00697697
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-12
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-16
• Primary Completion: 2009-08
• Study Completion: 2009-12
• Results First Submitted: 2013-08-19
• Results First Submitted QC: 2013-08-19
• Results First Posted: 2013-10-23
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 192

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.135mg MAP0010	0.135mg MAP0010	0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
0.25mg MAP0010	0.25mg MAP0010	0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks

Primary Outcome Measures

Name	Time	Method
Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination	40 weeks	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 With Treatment Emergent Adverse Events Related to Study Drug	40 weeks	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.