A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children - Full Text View

Sponsored by:	MAP Pharmaceuticals, Inc.
Information provided by:	MAP Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00569192

Purpose

The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.

Condition	Intervention	Phase
Asthma	Drug: MAP0010 Drug: Placebo	Phase III

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double Blind, Placebo Controlled, Parallel Group, Study Investigating the Safety and Efficacy Over 12 Weeks Treatment Period of MAP0010 in Asthmatic Infants and Children 12 Months to 8 Years of Age

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

Primary Outcome Measures:

To measure the change from baseline in nighttime and daytime composite symptom scores. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the change in clinic FEV1 from baseline. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
To evaluate lung function (PEF) [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
To evaluate e-diary symptoms (cough, wheeze, breathlessness) [ Time Frame: prospective ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	360
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator MAP0010 low dose	Drug: MAP0010 low dose; inhalation; twice daily
2: Active Comparator MAP0010 high dose	Drug: MAP0010 high dose; inhalation; twice daily
3: Placebo Comparator	Drug: Placebo 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:

Male or female asthmatic children with mild to moderate persistent asthma.
12 months to 8 years of age.
For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.
For infants age 12 to <48 months old: 2 or more wheezing episodes in past 12 months which lasted > 1 day and affected sleep.
AND with at least one major or two minor risk factors.

Exclusion Criteria:

Any other significant childhood illness/abnormality or chronic lung disease
Any history of upper or lower respiratory tract infection, within 2 weeks of screening.
Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.
Any use of oral corticosteroids within 30 days of screening or prolonged use (>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569192

Contacts

Contact: Chris Allen

650-861-7032

callen@mappharma.com

Locations

United States, California
	Recruiting
San Diego, California, United States

Sponsors and Collaborators

MAP Pharmaceuticals, Inc.

Investigators

Study Director:

Shahid Siddiqui, MD

MAP Pharmaceuticals

More Information

Responsible Party:	MAP Pharmaceuticals ( Dr Shahid Siddiqui/Director of Clinical Development )
Study ID Numbers:	MAP0010-CL-P301
Study First Received:	December 5, 2007
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00569192
Health Authority:	United States: Food and Drug Administration

Keywords provided by MAP Pharmaceuticals, Inc.:

asthmatic infants and children

Study placed in the following topic categories:

Asthma

ClinicalTrials.gov processed this record on January 15, 2009