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CLINICAL TRIALS PROFILE FOR OMNARIS

All Clinical Trials for Omnaris

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00458835 ↗	Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)	Completed	AstraZeneca	Phase 4	2007-04-01	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.
NCT01033825 ↗	Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis	Completed	Sunovion	Phase 3	2010-01-01	To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.
NCT01430260 ↗	Omnaris Versus Levocetirizine Phase 4 Study	Completed	Takeda	Phase 4	2011-01-01	This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.
NCT01430260 ↗	Omnaris Versus Levocetirizine Phase 4 Study	Completed	Handok Inc.	Phase 4	2011-01-01	This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.
NCT01430260 ↗	Omnaris Versus Levocetirizine Phase 4 Study	Completed	Handok Pharmaceuticals Co., Ltd.	Phase 4	2011-01-01	This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.
NCT01550471 ↗	Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis	Completed	West Penn Allegheny Health System	Phase 4	2012-03-01	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.

Clinical Trial Conditions for Omnaris

Condition Name

Condition Name for Omnaris
Intervention	Trials
Allergic Rhinitis	3
Perennial Allergic Rhinitis	2
Seasonal Allergic Rhinitis	2
Asthma	1

Condition MeSH

Condition MeSH for Omnaris
Intervention	Trials
Rhinitis, Allergic	7
Rhinitis	7
Rhinitis, Allergic, Perennial	2
Rhinitis, Allergic, Seasonal	2

Clinical Trial Locations for Omnaris

Trials by Country

Trials by Country for Omnaris
Location	Trials
United States	23
Canada	3
Korea, Republic of	1
Russian Federation	1

Trials by US State

Trials by US State for Omnaris
Location	Trials
Texas	3
Pennsylvania	2
New Jersey	2
Minnesota	2
Massachusetts	2

Clinical Trial Progress for Omnaris

Clinical Trial Phase

Clinical Trial Phase for Omnaris
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Omnaris
Clinical Trial Phase	Trials
Completed	7
Terminated	1

Clinical Trial Sponsors for Omnaris

Sponsor Name

Sponsor Name for Omnaris
Sponsor	Trials
AstraZeneca	2
Sunovion	2
Takeda	2

Sponsor Type

Sponsor Type for Omnaris
Sponsor	Trials
Industry	9
Other	2