A Study of 2 Doses of MAP0010 in Asthmatic Children

Allergan

Status and phase: Terminated; Phase 3

Conditions: Asthma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00697697

MAP0010-CL-P301X

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: All

Ages: 12 months to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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192 participants in 2 patient groups

0.135mg MAP0010

Experimental group

Description:

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

Treatment:

Drug: 0.135mg MAP0010

0.25mg MAP0010

Experimental group

Description:

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

Treatment:

Drug: 0.25mg MAP0010