Trial Outcomes & Findings for Safety and Blood Level Study of Unit Dose Budesonide (NCT NCT00627679)
NCT ID: NCT00627679
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
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
8 hours
Results posted on
2014-01-09
Participant Flow
All subjects received all 4 treatments in a randomly assigned order. The treatments were: Treatment A: Pulmicort Respules® Treatment B: MAP0010 low dose Treatment C: MAP0010 intermediate dose Treatment D: MAP0010 high dose The sequences were Treatments ABDC, BACD, CDBA, DACB.
Participant milestones
| Measure |
Treatment A, B, D, C
Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of 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 B, C, A, D
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 Pulmicort Respules® delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5
|
Treatment C, D, B, A
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 Pulmicort Respules® delivered by nebulization at Visit 5
|
Treatment D, A, C, B
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 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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Blood Level Study of Unit Dose Budesonide
Baseline characteristics by cohort
| Measure |
All Patients
n=16 Participants
All patients that were enrolled in the study.
|
|---|---|
|
Age, Continuous
|
23.3 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 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 |
Treatment A
n=16 Participants
a single dose of Pulmicort Respules® delivered by nebulization as per protocol
|
Treatment B
n=15 Participants
a single dose of MAP0010 low dose delivered by nebulization as per protocol
|
Treatment C
n=16 Participants
a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
|
Treatment D
n=16 Participants
a single dose of MAP0010 high dose delivered by nebulization as per protocol
|
|---|---|---|---|---|
|
Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010
|
303.5 pg/mL
Standard Deviation 177.4
|
106.2 pg/mL
Standard Deviation 63.47
|
239.9 pg/mL
Standard Deviation 140.1
|
434.5 pg/mL
Standard Deviation 246.9
|
PRIMARY outcome
Timeframe: 8 hoursPopulation: Patients with available data at specified time points are included in the analysis population.
Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).
Outcome measures
| Measure |
Treatment A
n=16 Participants
a single dose of Pulmicort Respules® delivered by nebulization as per protocol
|
Treatment B
n=15 Participants
a single dose of MAP0010 low dose delivered by nebulization as per protocol
|
Treatment C
n=16 Participants
a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
|
Treatment D
n=16 Participants
a single dose of MAP0010 high dose delivered by nebulization as per protocol
|
|---|---|---|---|---|
|
Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
|
9.063 min
Standard Deviation 7.122
|
4.467 min
Standard Deviation 3.270
|
3.125 min
Standard Deviation 1.500
|
3.688 min
Standard Deviation 1.448
|
PRIMARY outcome
Timeframe: 8 hoursPopulation: Patients with available data at specified time points are included in the analysis population.
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).
Outcome measures
| Measure |
Treatment A
n=16 Participants
a single dose of Pulmicort Respules® delivered by nebulization as per protocol
|
Treatment B
n=15 Participants
a single dose of MAP0010 low dose delivered by nebulization as per protocol
|
Treatment C
n=16 Participants
a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
|
Treatment D
n=16 Participants
a single dose of MAP0010 high dose delivered by nebulization as per protocol
|
|---|---|---|---|---|
|
AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010
|
29040 pg*min/mL
Standard Deviation 9316
|
3978 pg*min/mL
Standard Deviation 1974
|
8626 pg*min/mL
Standard Deviation 4184
|
22130 pg*min/mL
Standard Deviation 9675
|
PRIMARY outcome
Timeframe: 8 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 against time to infinity (inf) after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg\*min/ml).
Outcome measures
| Measure |
Treatment A
n=16 Participants
a single dose of Pulmicort Respules® delivered by nebulization as per protocol
|
Treatment B
n=12 Participants
a single dose of MAP0010 low dose delivered by nebulization as per protocol
|
Treatment C
n=13 Participants
a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
|
Treatment D
n=14 Participants
a single dose of MAP0010 high dose delivered by nebulization as per protocol
|
|---|---|---|---|---|
|
AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
|
31480 pg*min/mL
Standard Deviation 10690
|
4391 pg*min/mL
Standard Deviation 1423
|
7842 pg*min/mL
Standard Deviation 3647
|
25290 pg*min/mL
Standard Deviation 11750
|
PRIMARY outcome
Timeframe: 8 hoursHalf-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).
Outcome measures
| Measure |
Treatment A
n=16 Participants
a single dose of Pulmicort Respules® delivered by nebulization as per protocol
|
Treatment B
n=12 Participants
a single dose of MAP0010 low dose delivered by nebulization as per protocol
|
Treatment C
n=13 Participants
a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
|
Treatment D
n=14 Participants
a single dose of MAP0010 high dose delivered by nebulization as per protocol
|
|---|---|---|---|---|
|
Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
|
145.4 min
Standard Deviation 40.84
|
73.02 min
Standard Deviation 33.43
|
78.35 min
Standard Deviation 27.08
|
140.0 min
Standard Deviation 54.19
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment C
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment D
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=16 participants at risk
a single dose of Pulmicort Respules® delivered by nebulization as per protocol
|
Treatment B
n=16 participants at risk
a single dose of MAP0010 low dose delivered by nebulization as per protocol
|
Treatment C
n=16 participants at risk
a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
|
Treatment D
n=16 participants at risk
a single dose of MAP0010 high dose delivered by nebulization as per protocol
|
|---|---|---|---|---|
|
Vascular disorders
thrombophlebitis
|
0.00%
0/16
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/16
|
|
Vascular disorders
hematoma
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
epitaxis
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
pharyngolaryngeal pain
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/16
|
|
Nervous system disorders
headache
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/16
|
|
Infections and infestations
herpes simplex
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/16
|
|
Infections and infestations
vaginal candidiasis
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/16
|
|
Infections and infestations
hordeolum
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/16
|
0.00%
0/16
|
12.5%
2/16
|
6.2%
1/16
|
|
Reproductive system and breast disorders
dysmenorrhoea
|
12.5%
2/16
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
|
Eye disorders
eye irritation
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
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