Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MAP0010 low dose · 4 trials · 1 indication
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.
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.
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 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 against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg\*min/ml).
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) 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) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.
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 is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).
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).
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) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes (min).
| Arm | Type | Description |
|---|---|---|
| 0.25mg MAP0010 | EXPERIMENTAL | 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo delivered by nebulization twice daily for 12 weeks |
| 0.135mg MAP0010 | EXPERIMENTAL | 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks |
| Treatment 1 then Treatment 2 | OTHER | Subjects 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 1 | OTHER | Subjects 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 4 | OTHER | Subjects 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 3 | OTHER | Subjects 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 dose | EXPERIMENTAL | a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks |
| MAP0010 high dose | EXPERIMENTAL | a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks |
| Treatment sequence: A, B, D, C | EXPERIMENTAL | Treatment 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, D | EXPERIMENTAL | Treatment 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, A | EXPERIMENTAL | Treatment 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, B | EXPERIMENTAL | Treatment 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 |
| Name | Type | Description |
|---|---|---|
| 0.135mg MAP0010 | DRUG | 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks |
| 0.25mg MAP0010 | DRUG | 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks |
| Placebo | DRUG | Placebo delivered by nebulization twice daily for 12 weeks |
| MAP0010 low dose | DRUG | a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol |
| MAP0010 high dose | DRUG | a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol |
| Budesonide inhalation suspension 0.25mg | DRUG | a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol |
| Budesonide inhalation suspension 0.5mg | DRUG | a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol |
| Budesonide Inhalation Suspension | DRUG | Treatment 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 dose | DRUG | Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol. |
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...
MAP0010 low dose is an investigational small molecule being developed for the treatment of asthma. It is a respiratory therapeutic currently in Phase 3 clinical development. The drug has been studied in both adult and pediatric asthma patients, with completed trials involving children as young as 12 months.
MAP0010 low dose is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company has conducted multiple clinical trials of the drug in asthma patients across various age groups.
MAP0010 low dose is currently in Phase 3 clinical development for asthma. The drug has completed four clinical trials, including a Phase 3 study in asthmatic children. It remains investigational and has not been approved by regulatory authorities.
MAP0010 low dose has been studied in four completed clinical trials. These include NCT00554970, a Phase 2 study in 32 adult asthmatics; NCT00569192, a Phase 3 study in 360 asthmatic children; NCT00627679, a Phase 1 safety study in 16 healthy volunteers; and NCT00697801, a Phase 2 study in 208 asthmatic children and adolescents.
MAP0010 low dose is not the same as budesonide. One of its clinical trials, NCT00627679, was a safety and blood level study of unit dose budesonide, but MAP0010 low dose is a distinct investigational drug being developed by AbbVie for asthma. The two are separate compounds.