Aim of the study is to investigate the short-term growth in children with asthma aged 5-11 years in treatment with fluticasone propionate / formoterol spray (flutiform®) 200/20 micrograms per day
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
Asthma and Allergy Children's Clinic
Randers, Denmark
To show non-inferiority of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid) based on the mean lower leg growth rates.
Lower leg length will be measured in the afternoon, between 13:00 and 19:00h. Each individual subject will have their knemometry measurements performed at the same time of day (+/- 1 hour).
Time frame: Change from baseline in growth rate during the each treatment and washout period which is 2 weeks
To compare the safety of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg based on overnight urinary free cortisol (corrected for creatinine).
Subjects will empty their bladder into the toilet before going to bed at night (or no later than at 10pm). This urine will not be collected. This voiding time will be recorded as the start time of the urine collection. Urine passed after this time during the night (if any) and until 8 am in the morning will be collected into a clean container. Subjects will empty their bladders a final time at 8 am in to the container. This voiding time will be recorded as the stop time of the urine collection.
Time frame: every two weeks for duration of study which is two months.
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