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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR OMNARIS

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Clinical Trials for Omnaris

Trial ID Title Status Sponsor Phase 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 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 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 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 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 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.
NCT01654536 A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR) Completed Sunovion Phase 4 This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate the nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR.
Trial ID Title Status Sponsor Phase Summary

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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
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Condition MeSH

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

Trials by Country

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

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

Clinical Trial Phase

Clinical Trial Phase for Omnaris
Clinical Trial Phase Trials
Phase 4 4
Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Omnaris
Clinical Trial Phase Trials
Completed 7
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Clinical Trial Sponsors for Omnaris

Sponsor Name

Sponsor Name for Omnaris
Sponsor Trials
Takeda 2
Sunovion 2
Handok Pharmaceuticals Co., Ltd. 1
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Sponsor Type

Sponsor Type for Omnaris
Sponsor Trials
Industry 7
Other 1
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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
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Colorcon
Merck
Teva
Julphar
Harvard Business School
Citi
AstraZeneca

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