Expired Study
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San Diego, California


Purpose:

The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 in asthmatic children/adolescents.


Study summary:

This is a randomized, double blind, placebo controlled, 3 arm, parallel group, phase 2 study of MAP0010(UDB)in asthmatic children. Subjects who meet the study entrance criteria will be randomized to one of three treatment groups and receive their first and selected other doses under supervision in the clinic. All subjects will complete 6 weeks of dosing, with diary card data collection throughout and clinic lung function tests (in children of appropriate age and ability) at start, during and end of study treatment period.


Criteria:

Inclusion Criteria: - Male or female asthmatic children/adolescents - 1 to 18 years of age - FEV1 greater than or equal to 50% predicted normal (where obtainable) - Stable but symptomatic - Diagnosis of asthma (per NIH criteria) at least 3 months before screening OR documented exacerbation or worsening of asthma or symptoms suggestive of asthma including nocturnal asthma, within 6 months of screening OR documented SAB use more than or at least once for symptom relief during the 4 days of run in with a total symptom score greater than or equal to 1 OR greater than or equal to 1 night disturbed due to asthma symptoms in previous month. Exclusion Criteria: - Any other significant childhood illness. - Participated in any investigational clinical trial within the 30 days prior to screening. - Use of any corticosteroid within 2 weeks of screening. - Use of oral corticosteroid within 30 days of screening or prolonged use of oral corticosteroids within 12 weeks of screening. - Use of inhaled long acting bronchodilators. - Presumptive or documented history of upper or lower respiratory infection within 2 weeks before screening. - Any history of acute or severe asthma attack requiring ICU admission or ventilatory support. - History suggestive (or diagnosis) of other concomitant lung disease.


NCT ID:

NCT00697801


Primary Contact:

Study Director
Alan Cohen, MD
MAP Pharmaceuticals


Backup Contact:

N/A


Location Contact:

San Diego, California
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2018

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