This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
West Coast Clinical Trials LLC
Cypress, California, United States
Sylvana Research Associates
San Antonio, Texas, United States
Cmax of Budesonide After Administration of MAP0020
The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).
Time frame: 12 hours
AUC(0-inf) of Budesonide After Administration of MAP0020
The AUC(0-inf) is the area under the plot of plasma concentration of drug to time infinity after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg\*min/ml).
Time frame: 12 hours
Half-life (t1/2) of Budesonide After Administration of MAP0020
Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.
Time frame: 12 hours
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