Nasal Spray, 50 mcg
For intranasal use only
The active component of OMNARIS Nasal Spray is ciclesonide, a non-halogenated glucocorticoid.
OMNARIS Nasal Spray is indicated for the following:
Seasonal Allergic Rhinitis
OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older.
Perennial Allergic Rhinitis
OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with perennial allergic rhinitis in adults and adolescents 12 years of age and older.
Published Studies Related to Omnaris (Ciclesonide Nasal)
An investigation of the pharmacokinetics, pharmacodynamics, safety, and tolerability of ciclesonide hydrofluoroalkane nasal aerosol in healthy subjects and subjects with perennial allergic rhinitis. [2011.08]
Ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) is currently in development for treatment of allergic rhinitis. This Phase I study evaluated the pharmacokinetics, pharmacodynamics, safety, and tolerability of CIC-HFA in healthy subjects (N = 18) and subjects with perennial allergic rhinitis (PAR, N = 18) in a double-blind, placebo-controlled, 3-period crossover design following treatment with 282 mug or 148 mug CIC-HFA or placebo once-daily for 14 days...
Simultaneous determination of ciclesonide and its active metabolite desisobutyryl-ciclesonide in human plasma by LC-APCI-MS/MS: application to pharmacokinetic study in healthy Chinese volunteers. [2011.04.28]
A sensitive and highly selective liquid chromatography tandem mass spectrometric (LC/MS/MS) method was developed and validated for the determination of ciclesonide (CIC) and its active metabolite, desisobutyryl-ciclesonide (des-CIC), in human plasma... The method was fully validated and successfully applied to determine CIC and des-CIC simultaneously in human plasma and proved to be suitable for phase I clinical pharmacokinetic study of inhaled ciclesonide in healthy Chinese volunteers.
Comparison of the effect of low-dose ciclesonide and fixed-dose fluticasone propionate and salmeterol combination on long-term asthma control. [2011.02]
BACKGROUND: Patients with mild persistent asthma constitute about 70% of the asthma population; thus, it is important to know which first-line treatment is best for the management of mild asthma. We compared benefits of first-line treatment with ciclesonide and a combination of fluticasone and salmeterol in patients with mild asthma... CONCLUSIONS: In mild asthma, FP200/S100 prolonged time to first severe asthma exacerbation, and CIC160 and FP200/S100 were clinically equieffective for most measures of asthma control. Trial registry: ClinicalTrials.gov; No.: NCT00163358; URL: www.clinicaltrials.gov.
Evaluation of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol, 80 or 160 mug once daily, for the treatment of seasonal allergic rhinitis. [2010.12]
BACKGROUND: A hypotonic aqueous nasal spray of ciclesonide is indicated for the treatment of allergic rhinitis (AR). A new nasal aerosol formulation of ciclesonide containing a hydrofluoroalkane propellant delivered via a metered-dose inhaler (CIC-HFA) is currently in clinical development as a potential treatment for AR. OBJECTIVES: To study the efficacy and safety of once-daily administration of CIC-HFA 80 or 160 mug compared with placebo in subjects 12 years and older with seasonal AR (SAR)... CONCLUSIONS: In this study, once-daily treatment with CIC-HFA 80 or 160 mug demonstrated statistically significant improvements in nasal and ocular symptoms of SAR. Both doses of active treatment were well tolerated. Copyright (c) 2010 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
Efficacy and safety of ciclesonide in patients with severe asthma: a 12-week, double-blind, randomized, parallel-group study with long-term (1-year) follow-up. [2010.12]
CONCLUSIONS: Ciclesonide 320 mug b.i.d. sustained lung function and asthma symptoms in patients with severe asthma over 12 weeks' treatment, and maintained lung function during a 40-week EP; ciclesonide 640 mug b.i.d. did not provide additional benefits. Long-term use of ciclesonide was not associated with increased local AEs or negative effects on cortisol levels.
Clinical Trials Related to Omnaris (Ciclesonide Nasal)
A Study Evaluating the Effect of Inhaled and Nasal Corticosteroids on Short Term Growth in Pediatric Subjects With Mild Asthma & Allergic Rhinitis [Not yet recruiting]
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.
Omnaris Versus Levocetirizine Phase 4 Study [Recruiting]
ATEM (Alvesco Non-interventional Study) [Recruiting]
The aim of the study is to evaluate the efficacy of Alvesco in patients with persistent
asthma including or excluding allergic components over 3 months, especially in the spring
season. Alvesco will be inhaled by a metered-dose inhaler. The study will provide further
data on safety and tolerability of Alvesco .
A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR) [Recruiting]
This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group,
efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and
premenarchal female subjects 6 to 11 years-old diagnosed with SAR.
A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR). [Recruiting]
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled,
parallel-group, efficacy and safety study of ciclesonide nasal aerosol administered once
daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.
Reports of Suspected Omnaris (Ciclesonide Nasal) Side Effects
Confusional State (1),
Drug Ineffective (1),
Nasal Discomfort (1),
Intraocular Pressure Increased (1),
Upper-Airway Cough Syndrome (1),
Face Oedema (1),
Road Traffic Accident (1), more >>
Page last updated: 2011-12-09