Trial Outcomes & Findings for Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma (NCT NCT00995904)
NCT ID: NCT00995904
Last Updated: 2014-01-09
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
12 hours
Results posted on
2014-01-09
Participant Flow
This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 treatments in a randomly assigned order: treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA.
Participant milestones
| Measure |
Treatment A, Then Treatment B, Then Treatment C
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
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
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
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 MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
|
Treatment C, Then Treatment A, Then Treatment B
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
Study visits were separated by 3-7 day intervals. Treatment C: 21ug 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 A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
|
|---|---|---|---|---|---|---|
|
Visit 2 (Randomization)
STARTED
|
4
|
3
|
4
|
5
|
5
|
4
|
|
Visit 2 (Randomization)
COMPLETED
|
4
|
3
|
4
|
5
|
5
|
4
|
|
Visit 2 (Randomization)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Visit 3
STARTED
|
4
|
3
|
4
|
5
|
5
|
3
|
|
Visit 3
COMPLETED
|
4
|
3
|
4
|
5
|
5
|
3
|
|
Visit 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Visit 4
STARTED
|
4
|
3
|
4
|
5
|
5
|
3
|
|
Visit 4
COMPLETED
|
4
|
3
|
4
|
5
|
5
|
3
|
|
Visit 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up Visit (Final Visit)
STARTED
|
4
|
3
|
4
|
5
|
5
|
3
|
|
Follow-up Visit (Final Visit)
COMPLETED
|
4
|
3
|
4
|
5
|
5
|
3
|
|
Follow-up Visit (Final Visit)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma
Baseline characteristics by cohort
| Measure |
All Patients
n=25 Participants
All patients that were enrolled in the study.
|
|---|---|
|
Age, Continuous
|
8.3 years
STANDARD_DEVIATION 1.88 • n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 hoursPopulation: Patients with available data at specified time points are included in the analysis population.
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).
Outcome measures
| Measure |
21ug MAP0020
n=22 Participants
21ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
|
42ug MAP0020
n=22 Participants
42ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
|
84ug MAP0020
n=22 Participants
84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
|
|---|---|---|---|
|
Cmax of Budesonide After Administration of MAP0020
|
92.5 pg/ml
Standard Deviation 72.9
|
175 pg/ml
Standard Deviation 96.0
|
370 pg/ml
Standard Deviation 236
|
PRIMARY outcome
Timeframe: 12 hoursPopulation: Patients with available data at specified time points are included in the analysis population.
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).
Outcome measures
| Measure |
21ug MAP0020
n=22 Participants
21ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
|
42ug MAP0020
n=22 Participants
42ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
|
84ug MAP0020
n=22 Participants
84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
|
|---|---|---|---|
|
AUC(0-inf) of Budesonide After Administration of MAP0020
|
3750 pg*min/ml
Standard Deviation 1560
|
8710 pg*min/ml
Standard Deviation 3270
|
19400 pg*min/ml
Standard Deviation 8230
|
PRIMARY outcome
Timeframe: 12 hoursPopulation: Patients with available data at specified time points are included in the analysis population.
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.
Outcome measures
| Measure |
21ug MAP0020
n=22 Participants
21ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
|
42ug MAP0020
n=22 Participants
42ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
|
84ug MAP0020
n=22 Participants
84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
|
|---|---|---|---|
|
Half-life (t1/2) of Budesonide After Administration of MAP0020
|
53.3 minutes
Standard Deviation 31.2
|
74.6 minutes
Standard Deviation 29.8
|
86.9 minutes
Standard Deviation 29.0
|
Adverse Events
21ug MAP0020
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
42ug MAP0020
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
84ug MAP0020
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
21ug MAP0020
n=25 participants at risk
21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
|
42ug MAP0020
n=24 participants at risk
42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
|
84ug MAP0020
n=24 participants at risk
84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
8.0%
2/25
All 25 subjects who received 21ug MAP0020, 24 subjects who received 42ug MAP0020, and 24 subjects who received 84ug MAP0020 are included in the adverse event analysis.
|
4.2%
1/24
All 25 subjects who received 21ug MAP0020, 24 subjects who received 42ug MAP0020, and 24 subjects who received 84ug MAP0020 are included in the adverse event analysis.
|
0.00%
0/24
All 25 subjects who received 21ug MAP0020, 24 subjects who received 42ug MAP0020, and 24 subjects who received 84ug MAP0020 are included in the adverse event analysis.
|
Additional Information
VP, Scientific Affairs
MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan
Phone: 650-386-3100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER