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

Allergan

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: 0.25mg MAP0010; Drug: Placebo; Drug: 0.135mg MAP0010

Study type: Interventional

Funder types: Industry

Identifiers

NCT00569192

MAP0010-CL-P301

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 12 months to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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360 participants in 3 patient groups, including a placebo group

0.25mg MAP0010

Experimental group

Description:

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

Treatment:

Drug: 0.25mg MAP0010

Placebo

Placebo Comparator group

Description:

Placebo delivered by nebulization twice daily for 12 weeks

Treatment:

Drug: Placebo

0.135mg MAP0010

Experimental group

Description:

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

Treatment:

Drug: 0.135mg MAP0010