Rhinitis, Allergic, Perennial Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Clinical Trial Designed to Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, 200µg, 100µg or 25µg Once Daily for Six Weeks, in the Treatment of Perennial Allergic Rhinitis (PAR) in Pediatric Patients 2-5 Years of Age.
The primary objective of this study is to demonstrate the safety of three dose levels of
ciclesonide administered as an intranasal spray for six weeks, 200µg, 100µg or 25µg, once
daily, in pediatric patients (ages 2-5 years) with PAR. The secondary objective is to
measure serum concentrations of ciclesonide and its active metabolite under steady state
conditions at three time points corresponding to the presumed peak and trough exposure after
six weeks of administration.
In addition, reflective (24-hour) total nasal symptom score (TNSS) over the six weeks of
treatment at various timepoints and a physician assessment of nasal symptoms at endpoint
were summarized.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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