Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00995904 | Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma | PHASE2 | COMPLETED | 25 | — | — | Sep 1, 2009 | Nov 1, 2009 | Jan 9, 2014 | 2 | United States |
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).
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).
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.
| Arm | Type | Description |
|---|---|---|
| Treatment A, then Treatment B, then Treatment C | EXPERIMENTAL | Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 |
| Treatment A, then Treatment C, then Treatment B | EXPERIMENTAL | Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 |
| Treatment B, then Treatment A, then Treatment C | EXPERIMENTAL | Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 |
| Treatment B, then Treatment C, then Treatment A | EXPERIMENTAL | Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 4 |
| Treatment C, then Treatment A, then Treatment B | EXPERIMENTAL | Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 |
| Treatment C, then Treatment B, then Treatment A | EXPERIMENTAL | Study visits were separated by 3-7 day intervals. Treatment C: 21ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 2; Treatment B: 42ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 3; Treatment A: 84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 4 |
| Name | Type | Description |
|---|---|---|
| 84ug MAP0020 | DRUG | 84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol |
| 42ug MAP0020 | DRUG | 42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol |
| 21ug MAP0020 | DRUG | 21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol |
Key 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 ...