NCT00658918

To Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, in the Treatment of Perennial Allergic Rhinitis in Pediatrics (BY9010/M1-405)

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Rhinitis, Allergic, Perennial
• Hay Fever

Interventions

Type	Name	Description
DRUG	Ciclesonide nasal	safety of Ciclesonide (200µg, 100µg, 25µg)
DRUG	Placebo	placebo

Timeline

• Start date: 2004-09-01
• Primary completion: 2005-04-01
• Completion: 2005-11-01
• First posted: 2008-04-16
• Last updated: 2016-12-02

Locations

1 site across 1 country: United States