Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)
The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™
(ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide
HFA-metered-dose inhaler (MDI). The administration of the study medication will be as
follows: three single doses, separated by a wash-out period. The study will provide further
data on the safety and tolerability of ciclesonide.
Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis
West Penn Allegheny Health System
This study will provide the clinicians guidance on the safest combination of inhaled and
nasal corticosteroids for children with mild asthma and allergic rhinitis respectively;
however, one safety concern is that these products are independently known to have
dose-related effects on short term and intermediate term growth. Knemometry is a non
invasive technique for measuring short-term lower leg growth in children and is currently
the method of choice in growth studies of short duration. Subjects will be seen on a weekly
basis for 18 weeks and at each visit, lower leg length will be measured using knemometry.
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