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)

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.

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Drug: 0.135mg MAP0010; Drug: 0.25mg MAP0010

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.135mg MAP0010; 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks	Drug: 0.135mg MAP0010; 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
Experimental: 0.25mg MAP0010; 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks	Drug: 0.25mg MAP0010; 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Allergan
• Collaborators: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
• Investigators: Study Director: Medical Director, MAP Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: June 12, 2008
• First Submitted That Met QC Criteria: June 12, 2008
• First Posted (Estimate): June 16, 2008

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: asthmatic children
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: MAP0010-CL-P301X