A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents who have asthma. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
430
Change from Baseline in % predicted Forced Expiratory Volume in 1 second
Time frame: Week 2, 4 and 8, then at week 12
Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate
Time frame: Week 2, 4 and 8, then at week 12
Incidence of Adverse Events
Time frame: Week 2, 4 and 8, then at week 12
Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration
Time frame: 6 or 12 hours post dose
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