Recent Updates
Recently added Catalysts

MAP0020

Phase 2

Asthma | Small molecule | Respiratory |AbbVie Inc.|Trials Updated: Jan 9, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

MAP0020 clinical trials

MAP0020 · 1 trial · 1 indication

Phase 2 1
NCT00995904Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable AsthmaAsthma
COMPLETED25 Analytics
PHASE2COMPLETED
Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax of Budesonide After Administration of MAP0020
12 hours

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).

AUC(0-inf) of Budesonide After Administration of MAP0020
12 hours

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) of Budesonide After Administration of MAP0020
12 hours

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.

Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment A, then Treatment B, then Treatment CEXPERIMENTALStudy 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 BEXPERIMENTALStudy 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 CEXPERIMENTALStudy 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 AEXPERIMENTALStudy 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 BEXPERIMENTALStudy 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 AEXPERIMENTALStudy 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

Interventions

NameTypeDescription
84ug MAP0020DRUG84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
42ug MAP0020DRUG42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
21ug MAP0020DRUG21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Unlock Study Design Details

Eligibility Criteria

Age Range4 Years to 11 Years
SexALL
Healthy VolunteersNo
Study Sites2

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 ...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about MAP0020

What is MAP0020?

MAP0020 is an investigational small molecule developed by AbbVie Inc. for asthma, a respiratory condition. It has been studied in a Phase 2 clinical trial. The drug is also known as 84ug MAP0020. It is not yet approved for any indication and remains in clinical development.

What is MAP0020 used for in asthma?

MAP0020 is being developed for the treatment of mild-to-moderate stable asthma. It was evaluated in a Phase 2 trial in children aged 4 to 11 years. The study assessed tolerability and pharmacokinetics. MAP0020 is investigational and has not been approved for asthma or any other condition.

Who makes MAP0020?

MAP0020 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program for this investigational asthma therapy.

What phase is MAP0020 in?

MAP0020 is in Phase 2 clinical development for asthma. One Phase 2 trial has been completed. No Phase 3 trials have been registered. The drug is investigational and has not received FDA approval.

What clinical trials is MAP0020 in?

MAP0020 has been studied in one completed Phase 2 trial, NCT00995904, titled Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma. The trial enrolled 25 participants in the United States and was randomized and controlled.