A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-01-31

Brief Summary

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The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment 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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0.25mg MAP0010

0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

Group Type EXPERIMENTAL

0.25mg MAP0010

Intervention Type DRUG

0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

Placebo

Placebo delivered by nebulization twice daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo delivered by nebulization twice daily for 12 weeks

0.135mg MAP0010

0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

Group Type EXPERIMENTAL

0.135mg MAP0010

Intervention Type DRUG

0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

Interventions

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0.135mg MAP0010

0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

Intervention Type DRUG

0.25mg MAP0010

0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

Intervention Type DRUG

Placebo

Placebo delivered by nebulization twice daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female asthmatic children with mild to moderate persistent asthma.
* 12 months to 8 years of age.
* For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.
* For infants age 12 to \<48 months old: 2 or more wheezing episodes in past 12 months which lasted \> 1 day and affected sleep.
* AND with at least one major or two minor risk factors.

Exclusion Criteria

* Any other significant childhood illness/abnormality or chronic lung disease
* Any history of upper or lower respiratory tract infection, within 2 weeks of screening.
* Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
* Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.
* Any use of oral corticosteroids within 30 days of screening or prolonged use (\>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.

Minimum Eligible Age

12 Months

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No