Asthma
Conditions
Keywords
asthmatic children
Brief summary
This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery.
Interventions
DRUG84ug MAP0020
84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
DRUG42ug MAP0020
42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
DRUG21ug MAP0020
21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Sponsors
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male or female children with a documented diagnosis of mild-to-moderate persistent asthma (according to the 2007 NIH \[EPR\] criteria) for at least 1 year prior to screening and medically stable for a minimum of 6 months prior to screening. 2. Children 4 through 11 years old (up to one day prior to their 12th birthday at randomization). 3. Body weight \>=45 lbs, body mass index (BMI) \<=30 kg/m2 4. ICS users had to have been taking an ICS for \>=3 months and on a stable dose for \>= 1 month before Visit 1.ICS users had to be stable enough and able to withhold their therapeutic ICS for 24 hours prior to study drug administration, 5. Subjects already on stable immunotherapy (ie, allergy shots)if not anticipated to change during the study. Key
Exclusion criteria
1. Females of child-bearing potential/menarche. 2. Diagnosis of any other significant chronic illness or abnormality. 3. Use of corticosteroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of Budesonide After Administration of MAP0020 | 12 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). |
| AUC(0-inf) of Budesonide After Administration of MAP0020 | 12 hours | 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). |
| Half-life (t1/2) of Budesonide After Administration of MAP0020 | 12 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Patients All patients that were enrolled in the study. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 8.3 years STANDARD_DEVIATION 1.88 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 25 | 1 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 | 0 / 24 |
Outcome results
Primary
AUC(0-inf) of Budesonide After Administration of MAP0020
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).
Time frame: 12 hours
Population: Patients with available data at specified time points are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 21ug MAP0020 | AUC(0-inf) of Budesonide After Administration of MAP0020 | 3750 pg*min/ml | Standard Deviation 1560 |
| 42ug MAP0020 | AUC(0-inf) of Budesonide After Administration of MAP0020 | 8710 pg*min/ml | Standard Deviation 3270 |
| 84ug MAP0020 | AUC(0-inf) of Budesonide After Administration of MAP0020 | 19400 pg*min/ml | Standard Deviation 8230 |
Primary
Cmax of Budesonide After Administration of MAP0020
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).
Time frame: 12 hours
Population: Patients with available data at specified time points are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 21ug MAP0020 | Cmax of Budesonide After Administration of MAP0020 | 92.5 pg/ml | Standard Deviation 72.9 |
| 42ug MAP0020 | Cmax of Budesonide After Administration of MAP0020 | 175 pg/ml | Standard Deviation 96 |
| 84ug MAP0020 | Cmax of Budesonide After Administration of MAP0020 | 370 pg/ml | Standard Deviation 236 |
Primary
Half-life (t1/2) of Budesonide After Administration of MAP0020
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.
Time frame: 12 hours
Population: Patients with available data at specified time points are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 21ug MAP0020 | Half-life (t1/2) of Budesonide After Administration of MAP0020 | 53.3 minutes | Standard Deviation 31.2 |
| 42ug MAP0020 | Half-life (t1/2) of Budesonide After Administration of MAP0020 | 74.6 minutes | Standard Deviation 29.8 |
| 84ug MAP0020 | Half-life (t1/2) of Budesonide After Administration of MAP0020 | 86.9 minutes | Standard Deviation 29 |