OMNARIS SUMMARY
OMNARIS™
(ciclesonide)
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.
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NEWS HIGHLIGHTSMedia Articles Related to Omnaris (Ciclesonide Nasal)
Treatment Of Allergic Rhinitis Improves Coexisting Diseases
Source: Allergy News From Medical News Today [2009.11.09]
The treatment of allergic rhinitis is shown to improve co-existing conditions including conjunctivitis, asthma, sinusitis, otitis media with effusion (fluid in the middle ear) and sleep disorders according to an international expert at the annual meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Miami Beach, Fla.
Allergy drug tackles nasal congestion: study (Reuters)
Source: Y! Health Allergy News [2009.11.12]
Reuters - The "second generation" allergy drug desloratadine (brand name Clarinex) significantly reduces both the runny nose and congestion of seasonal and persistent allergic rhinitis, a study shows.
ACAAI: Drug Combo Effective in Allergic Eye Symptoms (CME/CE)
Source: MedPage Today Allergy & Immunology [2009.11.11]
MIAMI BEACH (MedPage Today) -- A combination of two standard drugs delivered together was safe and effective in treating the itchy and watery eyes associated with seasonal allergic rhinitis, a researcher said.
Published Studies Related to Omnaris (Ciclesonide Nasal)
Efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol once daily for the treatment of seasonal allergic rhinitis. [2009.08]
BACKGROUND: Aerosol-based corticosteroid nasal formulations may be preferred over current aqueous nasal sprays by some patients because they traditionally cause less pharyngeal and anterior nose runoff. OBJECTIVE: To determine the optimal dose, safety, and tolerability of ciclesonide hydrofluoroalkane nasal aerosol in patients with seasonal allergic rhinitis (SAR)... CONCLUSIONS: Ciclesonide hydrofluoroalkane nasal aerosol demonstrated statistically significant improvements in SAR symptoms vs placebo. On the basis of comparable efficacy and safety profiles observed for all doses, these results suggest that the 75-microg and 150-microg doses of ciclesonide hydrofluoroalkane appear appropriate for further evaluation of efficacy.
Effects of ciclesonide and fluticasone on cortisol secretion in patients with persistent asthma. [2009.06]
We compared the systemic and clinical effects of ciclesonide (CIC) and fluticasone propionate (FP) administered, in addition to CIC 160 microg x day(-1) and salmeterol 50 microg twice daily, in 32 patients with persistent asthma using a randomised double-blind, placebo-controlled, double-dummy, five-period crossover design...
Efficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma. [2009.06]
BACKGROUND: Ciclesonide is a new inhaled corticosteroid (ICS). Information about its clinical efficacy and safety in relation to other ICS in children is needed for clinical positioning. OBJECTIVE: This 12-week, randomized, double-blind, double-dummy, three-arm, parallel-group study compared the efficacy and safety of ciclesonide with fluticasone propionate in children with mainly moderate and severe persistent asthma... CONCLUSION: Once-daily ciclesonide has a clinical effect similar to that of fluticasone propionate, but does not suppress cortisol excretion, in children with moderate and severe asthma.
Efficacy and safety evaluation of ciclesonide in subjects with mild-to-moderate asthma not currently using inhaled corticosteroids. [2009.05]
Inhaled corticosteroids (ICSs) are a first-line treatment for persistent asthma. This study was designed to compare the efficacy and safety of ciclesonide (CIC) in subjects with mild-to-moderate persistent asthma not using an ICS... improved disease control in subjects with mild-to-moderate persistent asthma not using an ICS and provided greater improvements than CIC160 q.d.
Efficacy and safety evaluation of ciclesonide in mild-to-moderate persistent asthma previously treated with inhaled corticosteroids. [2009.05]
Inhaled corticosteroids (ICSs) are recommended as first-line treatment for persistent asthma. This study was designed to evaluate the ability of ciclesonide (CIC) in subjects with stable asthma previously receiving another ICS or ICS/long-acting beta(2)-agonist (LABA) to maintain asthma disease control...
Clinical Trials Related to Omnaris (Ciclesonide Nasal)
Ciclesonide for the Treatment of Airway Hyperresponsiveness (BY9010/CH-101) [Recruiting]
The study objective is to investigate in a placebo-controlled, double-blind manner the
effect of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as
having PD15 mannitol. Treatment medication will be administered as follows: 320 microgram
ciclesonide or placebo will be inhaled once daily. The study duration consists of a
treatment period of 4 weeks. The study will provide further data on safety of ciclesonide.
A Pilot Investigation of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray [Not yet recruiting]
Efficacy of Ciclesonide During the Cold Season in Patients Older Than 12 Years With Persistent Asthma [Recruiting]
The aim of the study is to evaluate the efficacy of ciclesonide in patients with persistent
asthma over 3 months, especially in the cold season. Ciclesonide will be inhaled by a
metered-dose inhaler. The study will provide further data on safety and tolerability of
ciclesonide.
Responsiveness of Lower Airways in Adult Patients (18-60 y) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101) [Recruiting]
The aim of this study is to compare the responsiveness of lower airways in adult patients
with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment
medication will be administered as follows: ciclesonide will be inhaled once daily at one
dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study
duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study
will provide further data on safety and tolerability of ciclesonide.
Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 y) (BY9010/CA-101) [Recruiting]
The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of
the number of asthma exacerbations in children with mild persistent asthma. Treatment
medication will be administered as follows: ciclesonide will be inhaled once daily, using one
of the two dose levels versus placebo together with other corticosteroids used as
intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a
treatment period (12 months). The study will provide further data on safety and tolerability
of ciclesonide.
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