The purpose of this study is to assess the effect of one of five possible study medications used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years with persistent asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
MF/F MDI 25/5 mcg, 2 inhalations twice a day (BID)
MF/F MDI 50/5 mcg, 2 inhalations BID
MF/F MDI 100/5 mcg, 2 inhalations BID
Change from Baseline in Plasma Cortisol Area Under the Curve (AUC) 0-24 hrs
Time frame: Baseline (Day 1) and Day 42
Change from Baseline in Plasma Cortisol Trough Concentration (Ctrough)
Time frame: Baseline (Day 1) and Day 42
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BDP HFA 80 mcg, 2 inhalations BID
Montelukast chewable tablets 5 mg once daily (QD) for children 6-11 years of age OR Montelukast chewable tablets 4 mg QD for children 5 years of age
albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed
Prednisone/Prednisolone for rescue medication, taken as directed