A Study Investigating the Tolerability and Pharmacokinetics of Submicron Budesonide in Children 4 Through 11 Years Old With a History of Mild-To-Moderate Stable Asthma
Information source: MAP Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: submicron budesonide (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: MAP Pharmaceuticals, Inc. Overall contact:
Jean Chang, Phone: 650-386-3100
Summary
This Phase 2 study will investigate the tolerability of submicron budesonide at three doses
in volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate
the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery. This
study is designed to evaluate the systemic exposure of a new submicron budesonide
formulation in a next generation nebulizer.
Clinical Details
Official title: A Randomized, Open-Label, 3-Dose, 3-Period, Crossover Phase 2 Study Investigating the Tolerability and Pharmacokinetics of MAP0010 in Children 4 Through 11 Years Old With a History of Mild-To-Moderate Stable Asthma
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Safety Study
Primary outcome: Evaluate the pharmacokinetic profile of submicron budesonide resulting from inhalation aerosol delivery. The following pharmacokinetic parameters computed include Cmax, tmax, AUC0-last, AUC0-12, AUC1-inf, CL, kel, t ½, λ, and relative bioavailability.
Secondary outcome: Evaluate the safety and tolerability (adverse events) of a single dose of submicron budesonide via inhalation aerosol delivery.
Eligibility
Minimum age: 4 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or female children with a documented diagnosis of mild-to-moderate persistent
asthma (according to the 2007 NIH [EPR] criteria) for at least 1 year prior to
screening and medically stable for a minimum of 6 months prior to screening.
2. Children 4 through 11 years old (up to one day prior to their 12th birthday at
randomization).
Locations and Contacts
Jean Chang, Phone: 650-386-3100
Cypress, California, United States; Recruiting
San Antonio, Texas, United States; Recruiting
Additional Information
Starting date: September 2009
Ending date: January 2010
Last updated: October 14, 2009
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