| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00569192 | A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children | PHASE3 | COMPLETED | 360 | — | — | Dec 1, 2007 | Jan 1, 2009 | Jan 9, 2014 | - | — |
| NCT00554970 | A Study of 2 Doses of MAP0010 in Adult Asthmatics | PHASE2 | COMPLETED | 32 | — | — | Nov 1, 2007 | Mar 1, 2008 | Jan 9, 2014 | 1 | United States |
| NCT00697801 | Study of MAP0010 in Asthmatic Children and Adolescents | PHASE2 | COMPLETED | 208 | — | — | Jul 1, 2006 | Dec 1, 2006 | Jan 9, 2014 | 1 | United States |
| NCT00627679 | Safety and Blood Level Study of Unit Dose Budesonide | PHASE1 | COMPLETED | 16 | — | — | Dec 1, 2005 | May 1, 2006 | Jan 9, 2014 | 1 | Australia |
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...