A Study of 2 Doses of MAP0010 in Asthmatic Children

Asthma Clinical Trial

Official title:

A Randomized, Double-blind, Active-controlled, Phase 3 Extension Study Investigating the Safety and Efficacy Over 40 Weeks of 2 Doses of MAP0010 in Asthmatic Children (12 Months to 8 Years Old at the Time of Enrollment Into the MAP0010-CL-P301 Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00697697
• Other study ID #: MAP0010-CL-P301X
• Status: Terminated
• Phase: Phase 3
• First received: June 12, 2008
• Last updated: December 9, 2013
• Start date: April 2008
• Est. completion date: December 2009

Study information

• Verified date: December 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 192
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 8 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 0.135mg MAP0010
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Allergan	MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Treatment Emergent Adverse Events Related to Study Drug	A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.	40 weeks	Yes
Primary	Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination	A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.	40 weeks	Yes