Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MAP0020 · 1 trial · 1 indication
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 ...
MAP0020 is an investigational small molecule being developed for the treatment of asthma. It is currently in Phase 2 clinical development and has been studied in pediatric patients with mild-to-moderate stable asthma.
MAP0020 is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with asthma.
MAP0020 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug remains under evaluation for the treatment of asthma.
MAP0020 has been studied in one completed Phase 2 clinical trial, NCT00995904, which evaluated the tolerability and pharmacokinetics of submicron budesonide in children aged 4 to 11 years with mild-to-moderate stable asthma. The trial enrolled 25 participants in the United States.
MAP0020 is a submicron formulation of budesonide, a corticosteroid used to treat asthma. The Phase 2 trial NCT00995904 specifically assessed the tolerability and pharmacokinetics of this submicron budesonide formulation in pediatric patients with asthma.