A Study of 2 Doses of MAP0010 in Asthmatic Children

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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0.135mg MAP0010

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

Group Type EXPERIMENTAL

0.135mg MAP0010

Intervention Type DRUG

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

0.25mg MAP0010

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

Group Type EXPERIMENTAL

0.25mg MAP0010

Intervention Type DRUG

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

Interventions

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0.135mg MAP0010

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

Intervention Type DRUG

0.25mg MAP0010

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Months

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No