A Study of 2 Doses of MAP0010 in Asthmatic Children

Phase 3TerminatedNCT00697697

Allergan192 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

192

Conditions

Asthma

Interventions

0.135mg MAP0010DRUG

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

0.25mg MAP0010DRUG

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

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 8 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 40 weeks

Data from ClinicalTrials.gov

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