MedPath

Ciclesonide

Generic Name
Ciclesonide
Brand Names
Alvesco, Omnaris, Zetonna
Drug Type
Small Molecule
Chemical Formula
C32H44O7
CAS Number
126544-47-6
Unique Ingredient Identifier
S59502J185
Background

Ciclesonide is a glucocorticoid used to treat obstructive airway diseases. It is marketed under the brand name Alvesco.

Indication

For the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older.

Associated Conditions
Asthma, Bronchoconstriction, Chronic Obstructive Pulmonary Disease (COPD), Perennial Allergic Rhinitis (PAR), Seasonal Allergic Rhinitis

Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of Butylated Hydroxytoluene and BI 54903 XX Via Respimat® Soft MistTM Inhaler B in Healthy Male Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: BI 54903 XX high
Drug: BI 54903 XX medium 2
Drug: BI 54903 XX low
Drug: BI 54903 XX medium 1
First Posted Date
2014-08-20
Last Posted Date
2014-08-20
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
56
Registration Number
NCT02221375

Efficacy and Safety of Ciclesonide Nasal Spray in Participants With Seasonal Allergic Rhinitis (SAR) in Russia

Phase 3
Completed
Conditions
Seasonal Allergic Rhinitis
Interventions
First Posted Date
2014-06-04
Last Posted Date
2017-02-02
Lead Sponsor
AstraZeneca
Target Recruit Count
80
Registration Number
NCT02155881

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)

Phase 4
Completed
Conditions
Perennial Allergic Rhinitis
Interventions
First Posted Date
2012-07-31
Last Posted Date
2014-07-24
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
737
Registration Number
NCT01654536
Locations
🇺🇸

Kerrville Research Associates, PA, Kerrville, Texas, United States

🇺🇸

Clinical Research Group of Montanta, Bozeman, Montana, United States

🇺🇸

Valley Clinical Research Center, Bethlehem, Pennsylvania, United States

and more 28 locations

A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)

Phase 3
Completed
Conditions
Seasonal Allergic Rhinitis
Interventions
First Posted Date
2011-10-24
Last Posted Date
2014-05-15
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
847
Registration Number
NCT01458275
Locations
🇺🇸

Dallas Allergy Immunology Research, Dallas, Texas, United States

🇺🇸

Kerrville Research Associates, Kerrville, Texas, United States

🇺🇸

San Jose Multispecialty Medical Group, Inc, Baldwin Park, California, United States

and more 61 locations

Effect of High Dose Ciclesonide on Asthma Control

Phase 3
Completed
Conditions
Bronchial Asthma
Interventions
First Posted Date
2011-10-19
Last Posted Date
2017-02-10
Lead Sponsor
AstraZeneca
Target Recruit Count
520
Registration Number
NCT01455194

A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).

Phase 3
Completed
Conditions
Perennial Allergic Rhinitis
PAR
Interventions
First Posted Date
2011-10-13
Last Posted Date
2014-05-06
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
848
Registration Number
NCT01451541
Locations
🇺🇸

Sansum Clinic, Santa Barbara, California, United States

🇺🇸

West Coast Clinical Trials, LLC, Costa Mesa, California, United States

🇺🇸

National Allergy, Ashtma, and Urticaria Centers of Charleston, PA, North Charleston, South Carolina, United States

and more 55 locations

Omnaris Versus Levocetirizine Phase 4 Study

Phase 4
Completed
Conditions
Allergic Rhinitis
Interventions
First Posted Date
2011-09-08
Last Posted Date
2012-09-06
Lead Sponsor
Handok Inc.
Target Recruit Count
349
Registration Number
NCT01430260
Locations
🇰🇷

handok pharmaceuticals co. LTD, Seoul, Korea, Republic of

Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray

Phase 3
Completed
Conditions
Perennial Allergic Rhinitis
Interventions
First Posted Date
2011-07-25
Last Posted Date
2013-04-30
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
327
Registration Number
NCT01401465
Locations
🇺🇸

The Clinical Research Center, L.L.C., St. Louis, Missouri, United States

🇺🇸

Clinical Research Institute of Southern Oregon, PC, Medford, Oregon, United States

🇺🇸

Pharmacuetical Research & Consulting, Inc., Dallas, Texas, United States

and more 12 locations

Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis

Phase 3
Completed
Conditions
PAR
Perennial Allergic Rhinitis
Interventions
First Posted Date
2011-06-22
Last Posted Date
2014-05-26
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
89
Registration Number
NCT01378429
Locations
🇺🇸

Sneeze, Wheeze, & Itch Associates, LLC, Normal, Illinois, United States

🇺🇸

West Coast Clinical Trials, Costa Mesa, California, United States

🇺🇸

Clinical Research Atlanta, Stockbridge, Georgia, United States

and more 4 locations

A Phase 1 Scintigraphy Study to Assess Nasal Deposition of Ciclesonide. Using a Novel Nasal Metered Dose Inhaler

Phase 1
Completed
Conditions
Allergic Rhinitis (AR)
Interventions
First Posted Date
2011-06-13
Last Posted Date
2012-09-10
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
14
Registration Number
NCT01371786
Locations
🇬🇧

Quotient Clinical, Ruddington Fields, Ruddington, United Kingdom

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