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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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)

A 6 Month Randomized, Open Label, Parallel Group, Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis

NCT01654536•Sumitomo Pharma America, Inc.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This is a 6 month, multicenter, randomized, open label, parallel group, safety study of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR. The objectives of this study are to evaluate the nasal and ocular safety of once daily dosing with ciclesonide nasal aerosol (Zetonna) 74 mcg and ciclesonide aqueous nasal spray (Omnaris) 200 mcg in subjects 12 years and older with PAR.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject or Subject's parent/guardian gives written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
•Male or female 12 years and older, as of the Screening visit.
•Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, medical history.
•A history of PAR to a relevant perennial allergen (eg, house dust mites, cockroach, molds, animal dander) for a minimum of one year immediately preceding the study Screening visit. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past 12 months, and require treatment throughout the entire study period.
•Subject, if female ≤ 65 years of age, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:
•* An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
•* Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
•* Abstinence.
•Subject must possess an educational level and degree of understanding of English that enables them to communicate suitably with the PI and study coordinator.

Exclusion Criteria

•Female subject who is pregnant or lactating.
•Current physical findings of nasal polyps, septal perforation, or nasal ulceration. (Subjects showing significant progression of nasal pathology between screening and randomization would be excluded at the discretion of the investigator.\]
•Planned insertion of nasal septal jewelry during the study period.
•Surgery (including biopsy) and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 30 days prior to the Screening visit.
•Participation in any investigational drug trial within the 30 days preceding the Screening visit or planned participation in another investigational drug trial at any time during this trial.
•A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
•History of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, influenza, severe acute respiratory syndrome (SARS)\] within the 14 days preceding the Screening visit.
•History of alcohol or drug abuse within 2 years preceding the Screening visit.
•History of a positive test for HIV, hepatitis B or hepatitis C.
•Active asthma requiring treatment with inhaled or systemic corticosteroids.
+22 more criteria

Locations (31)

Allergy & Asthma Associates of Southern California

Mission Viejo, California, United States

CHOC PSF AMC - Division of Allergy, Asthma and Immunology

Orange, California, United States

Allergy Associates Medical Group Inc.

San Diego, California, United States

Bensch Research Associates

Stockton, California, United States

Storms Clinical Research Institute

Colorado Springs, Colorado, United States

DataQuest Medical Research LLC

Lawerenceville, Georgia, United States

Asthma & Allergy Consultants, PC

Lilburn, Georgia, United States

Gordon D Raphael, MD

Bethesda, Maryland, United States

Medical Education and Research Management Services of New England

Gardner, Massachusetts, United States

Northeast Medical Research Associates, Inc.

North Dartmouth, Massachusetts, United States

Key Dates

Start Date

September 1, 2012

Primary Completion Date

July 1, 2013

Completion Date

July 1, 2013

Last Updated

July 24, 2014

Enrollment

737

ACTUAL participants

Conditions

Perennial Allergic Rhinitis

Interventions

ciclesonide nasal aerosol

DRUG

ciclesonide nasal spray

DRUG

A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

NCT01425632

Perennial Allergic Rhinitis

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TERMINATEDPHASE3

Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis

NCT04874714

Allergic RhinoconjunctivitisPerennial Allergic Rhinitis+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

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