To compare the pharmacokinetics of budesonide delivered by BDA MDI to budesonide delivered by Pulmicort Respules in children with Asthma aged 4 to 8 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose.
Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide.
IPS Research
Oklahoma City, Oklahoma, United States
TTS Research
Boerne, Texas, United States
AUC0-t
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration
Time frame: A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing.
Cmax
Maximum observed plasma concentration
Time frame: A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing.
Tmax
Time to reach maximum observed plasma concentration
Time frame: A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing.
Tlast
Time of last quantifiable plasma concentration
Time frame: A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing.
Clast
Drug concentration at last observed (quantifiable) concentration
Time frame: A total of 10 samples were taken per treatment visit at pre-dose and at 10, 20, 40, 60, 120, 240, 360, 480 and 720 minutes after dosing.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.