NCT01033825

Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis

A 6-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of the Potential Inhibitory Effects on the Hypothalamic-Pituitary-Adrenal Axis of Ciclesonide HFA Nasal Aerosol and Ciclesonide Aqueous Nasal Spray in Subjects 12 Years and Older With Perennial Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety and efficacy study of the effects of ciclesonide HFA nasal aerosol and ciclesonide AQ nasal spray on the HPA axis, when administered once daily to male and female subjects 12 years or older diagnosed with Perennial Allergic Rhinitis (PAR). The study consists of a screening period, a single blind run in period, a 6 week double blind treatment period including an active control segment, and a follow up period. Placebo was used as the control during the double-blind treatment period for both delivery methods (HFA nasal aerosol and aqueous nasal spray)and for the study outcome analyses. There was also a positive control administered to a subset of these placebo subjects during the last 4 days of Week 6 (dexamethasone placebo or dexamethasone 6 mg). The active control was utilized to validate the assay sensitivity (ie, distinguish an effective from an ineffective drug) of this study, as dexamethasone is a known HPA axis suppressant, therefore this subset of placebo subjects was not included in the study outcome analyses. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Conditions

• Perennial Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Ciclesonide HFA Nasal Aerosol 320 mcg	Ciclesonide HFA Nasal Aerosol 320 μg once daily
DRUG	Ciclesonide HFA Nasal Aerosol 160 mcg	Ciclesonide HFA Nasal Aerosol 160 μg once daily
DRUG	HFA Nasal Aerosol placebo	HFA Nasal Aerosol placebo once daily
DRUG	Ciclesonide Aqueous Nasal Spray 200 mcg	Ciclesonide Aqueous Nasal Spray 200 mcg once daily
DRUG	AQ Nasal Spray Placebo	AQ Nasal Spray Placebo once daily
DRUG	Placebo plus Dexamethasone HFA	Dexamethasone capsules 6 mg once daily
DRUG	Placebo AQ plus Dexamethasone 6 mg	Placebo AQ plus Dexamethasone 6 mcg capsules once daily

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-12-17
• Last updated: 2012-07-19
• Results posted: 2012-07-19

Locations

6 sites across 1 country: United States