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A Study of 2 Doses of MAP0010 in Asthmatic Children

This study has been terminated.
(Corporate decision)
Sponsor:
Information provided by:
MAP Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00697697
First received: June 12, 2008
Last updated: November 13, 2009
Last verified: November 2009
History of Changes
  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: 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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by MAP Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • To investigate the safety of two doses of MAP0010 in asthmatic children (12 months to 8 years old at the time of enrollment into the MAP0010-CL-P301 Study) over a 40-week period. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate individual symptom score and composite symptom score for daytime and nighttime respectively. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • To evaluate days and nights free of all symptoms. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • To evaluate daytime and nighttime use of rescue medication. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • To evaluate rescue medication-free days and nights. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • To evaluate treatment compliance. [ Time Frame: Prospective ] [ Designated as safety issue: No ]
  • To evaluate time to asthma deterioration and the proportion of patients who have withdrawn from treatment because of asthma deterioration. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Enrollment: 192
Study Start Date: April 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
MAP0010 low dose
 Drug: MAP0010
low dose; inhalation; twice daily
Active Comparator: 2
MAP0010 high dose
 Drug: MAP0010
high dose; inhalation; twice daily

  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
MAP Pharmaceuticals, Inc.
Investigators
Study Director: Alan Cohen, MD MAP Pharmaceuticals
  More Information

No publications provided

Responsible Party: Alan Cohen/ VP Clinical Development and Medical Affairs, MAP Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00697697     History of Changes
Other Study ID Numbers: MAP0010-CL-P301X
Study First Received: June 12, 2008
Last Updated: November 13, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by MAP Pharmaceuticals, Inc.:
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 May 16, 2013