Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis

Perennial Allergic Rhinitis Clinical Trial

Official title: A 6-Week Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR)

Status Completed

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.

Clinical Trial Description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.

The study requires that subjects be domiciled during two 24- to 36-hour time periods for sample collection for serum and urinary free cortisol measurements, as well as PK evaluations (single [predose] time point during the first domiciled period, and 24-hour sampling during the second domiciled period). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PAR
• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

• NCT number: NCT01378429
• Study type: Interventional
• Source: Sunovion
• Status: Completed
• Phase: Phase 3
• Start date: July 2011
• Completion date: November 2011