A Study of 2 Doses of MAP0010 in Asthmatic Children

This study has been terminated.
(Corporate decision)
Sponsor:
Collaborator:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00697697
First received: June 12, 2008
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: 0.135mg MAP0010
Drug: 0.25mg MAP0010
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Number of Patients With Treatment Emergent Adverse Events Related to Study Drug [ Time Frame: 40 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination [ Time Frame: 40 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 192
Study Start Date: April 2008
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.135mg MAP0010
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
Drug: 0.135mg MAP0010
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
Experimental: 0.25mg MAP0010
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
Drug: 0.25mg MAP0010
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks

  Eligibility

Ages Eligible for Study:   12 Months to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697697

Sponsors and Collaborators
Allergan
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Investigators
Study Director: Medical Director MAP Pharmaceuticals
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00697697     History of Changes
Other Study ID Numbers: MAP0010-CL-P301X
Study First Received: June 12, 2008
Results First Received: August 19, 2013
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Allergan:
asthmatic children

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014