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
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 April 15, 2014