Study compares the efficacy and safety of FLUTIFORM® with Seretide® in the treatment of mild to moderate persistent asthma in pediatric subjects.
This is a study involving a 12 week treatment phase followed by a 6 month extension phase. During the treatment phase subjects receive FLUTIFORM® or Seretide®. In the extension phase all subjects receive FLUTIFORM®. Efficacy will be assessed by lung function tests and asthma symptoms, sleep disturbance. Safety will be assessed by adverse events, vital signs, lab tests and ECGs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
211
Unnamed facility
Prague, Czechia
Unnamed facility
Laon, France
Unnamed facility
Wiesal, Germany
Unnamed facility
Budapest, Hungary
Unnamed facility
Lublin 20-093, W. Chodzki 2, Poland
FEV1, recorded at visits to investigator at 2 wks, 6wks & 12 wks.
Lung function tests, peak expiratory flow rate, asthma symptoms & exacerbations, adverse events, sleep disturbance, rescue medication use, plasma cortisol (extension only).
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Unnamed facility
Bucharest, Romania