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MAP0010 low dose

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials4
Total Enrollment616
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00569192A Study of 2 Doses of MAP0010 and Placebo in Asthmatic ChildrenPHASE3 COMPLETED 360Dec 1, 2007Jan 1, 2009Jan 9, 2014 -
NCT00554970A Study of 2 Doses of MAP0010 in Adult AsthmaticsPHASE2 COMPLETED 32Nov 1, 2007Mar 1, 2008Jan 9, 20141 United States
NCT00697801Study of MAP0010 in Asthmatic Children and AdolescentsPHASE2 COMPLETED 208Jul 1, 2006Dec 1, 2006Jan 9, 20141 United States
NCT00627679Safety and Blood Level Study of Unit Dose BudesonidePHASE1 COMPLETED 16Dec 1, 2005May 1, 2006Jan 9, 20141 Australia
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Study Endpoints
Primary Endpoints
Change From Baseline in Daytime Composite Symptom Score
baseline, week 12

The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 7 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.

Change From Baseline in Nighttime Composite Symptom Score
baseline, week 12

The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 7 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.

Cmax of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
Day 1 hour 12

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).

Cmax of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
Day 8 hour 12

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 on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
Day 1 hour 12

The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg\*min/ml).

AUC(0-inf) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
Day 8 hour 12

The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg\*min/ml).

Half-life (t1/2) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
Day 1 hour 12

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.

Half-life (t1/2) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
Day 8 hour 12

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.

Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010
8 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).

Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
8 hours

Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).

AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010
8 hours

The AUC(0-8) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-8) is reported in picograms times minutes per milliliter (pg\*min/ml).

AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
8 hours

The AUC(0-inf) is the area under the plot of plasma concentration of drug against time to infinity (inf) 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 Pulmicort Respules® and Three Dose Levels of MAP0010
8 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 (min).

Secondary Endpoints
Change From Baseline in FEV1% Predicted
baseline, week 12
Change From Baseline in PEF
baseline, week 12
Change From Baseline in Daytime Individual Symptom Scores
baseline, week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
0.25mg MAP0010EXPERIMENTAL0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
PlaceboPLACEBO_COMPARATORPlacebo delivered by nebulization twice daily for 12 weeks
0.135mg MAP0010EXPERIMENTAL0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
Treatment 1 then Treatment 2OTHERSubjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
Treatment 2 then Treatment 1OTHERSubjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
Treatment 3 then Treatment 4OTHERSubjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
Treatment 4 then Treatment 3OTHERSubjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
MAP0010 low doseEXPERIMENTALa single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
MAP0010 high doseEXPERIMENTALa single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
Treatment sequence: A, B, D, CEXPERIMENTALTreatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 4; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 5
Treatment sequence: B, C, A, DEXPERIMENTALTreatment visits were separated by a 48-72 hour washout period. Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 2; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 3; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5
Treatment sequence: C, D, B, AEXPERIMENTALTreatment visits were separated by a 48-72 hour washout period. Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 2; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 3; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 4; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 5
Treatment sequence: D, A, C, BEXPERIMENTALTreatment visits were separated by a 48-72 hour washout period. Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 2; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 3; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 4; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 5
Interventions
NameTypeDescription
0.135mg MAP0010DRUG0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
0.25mg MAP0010DRUG0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
PlaceboDRUGPlacebo delivered by nebulization twice daily for 12 weeks
MAP0010 low doseDRUGa single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
MAP0010 high doseDRUGa single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
Budesonide inhalation suspension 0.25mgDRUGa single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol
Budesonide inhalation suspension 0.5mgDRUGa single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
Budesonide Inhalation SuspensionDRUGTreatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
MAP0010 intermediate doseDRUGTreatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
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Eligibility Criteria
Age Range12 Months — 8 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Male or female asthmatic children with mild to moderate persistent asthma. * 12 months to 8 years of age. * For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria. * For infants age 12 to \<48 months old: 2 or...

Countries:United StatesAustralia
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