Study of MAP0010 in Asthmatic Children and Adolescents

Allergan

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: MAP0010 low dose; Drug: MAP0010 high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00697801

MAP0010-CL-P201

Details and patient eligibility

About

The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.

Enrollment: 208 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female asthmatic children/adolescents
• 1 to 18 years of age
• FEV1 greater than or equal to 50% predicted normal (where obtainable)
• Stable but symptomatic
• Diagnosis of asthma (per NIH criteria) at least 3 months before screening OR documented exacerbation or worsening of asthma or symptoms suggestive of asthma including nocturnal asthma, within 6 months of screening OR documented SAB use more than or at least once for symptom relief during the 4 days of run in with a total symptom score greater than or equal to 1 OR greater than or equal to 1 night disturbed due to asthma symptoms in previous month.

Exclusion criteria

• Any other significant childhood illness.
• Participated in any investigational clinical trial within the 30 days prior to screening.
• Use of any corticosteroid within 2 weeks of screening.
• Use of oral corticosteroid within 30 days of screening or prolonged use of oral corticosteroids within 12 weeks of screening.
• Use of inhaled long acting bronchodilators.
• Presumptive or documented history of upper or lower respiratory infection within 2 weeks before screening.
• Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
• History suggestive (or diagnosis) of other concomitant lung disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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208 participants in 3 patient groups, including a placebo group

MAP0010 low dose

Experimental group

Description:

a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks

Treatment:

Drug: MAP0010 low dose

MAP0010 high dose

Experimental group

Description:

a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks

Treatment:

Drug: MAP0010 high dose

Placebo

Placebo Comparator group

Description:

Placebo delivered by nebulization twice daily for 6 weeks

Treatment:

Drug: Placebo