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 · Phase 4

Conditions studied: Perennial Allergic Rhinitis

In brief

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.

Key facts

Study ID: NCT01654536
Run by: Sumitomo Pharma America, Inc.
People needed: 737
Starts: 2012-09-01
Expected to finish: 2013-07-01
Last updated by the study team: 2014-07-24

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.
Use of chronic treatment with agents known to promote the development of cataracts (potassium-sparing diuretics and allopurinol).
Non vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit.
Initiation of pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during the study period or planned dose escalation during the study period. However, initiation of these creams/ointments 30 days or more prior to screening and use of a stable (maintenance) dose during the study period may be considered for inclusion.
Use of nasal corticosteroids within 14 days, or ocular, oral or parenteral within 6 months prior to randomization.
Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial:
impaired hepatic function including alcohol related liver disease or cirrhosis
diabetes mellitus
malignancy (excluding basal cell carcinoma)
Any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written Ocular Exclusion Criteria
History of bacterial or viral infection of the eyes within 14 days of the Screening visit or current or history of ocular herpes simplex.
Any use within 6 months prior to the randomization or planned use during the trial of a topical ocular corticosteroid, or intraocular or periocular injection of corticosteroids.
Progressive retinal (including, but not limited to acute macular degeneration or unstable diabetic retinopathy) or optic nerve disease in either eye.
Ocular injury/surgery in the last 6 months (including LASIK eye surgery, as well as any glaucoma intraocular surgery, including laser trabeculoplasty [ALT or SLT]).
Any evidence of glaucomatous optic disc changes or a vertical cup:disc ratio > 0.8.
Current or history of any glaucoma related diagnosis, including ocular hypertension, open-angle or closed-angle, as well as secondary or congenital glaucoma.

Where it is running

Respiratory Medicine Research Institute of Michigan, PLC — Ypsilanti, Michigan, United States
Clinical Research Institute Inc. — Minneappolis, Minnesota, United States
The Clinical Research Center, LLC — St Louis, Missouri, United States
Clinical Research Group of Montanta — Bozeman, Montana, United States
Ocean Allergy & Respiratory Research Center — Brick, New Jersey, United States
Atlantic Research Center, LLC — Ocean City, New Jersey, United States
Princeton Center for Clinical Research — Skillman, New Jersey, United States
Allergy and Asthma Center of NC, PA — High Point, North Carolina, United States
North Carolina Clinical Research — Raleigh, North Carolina, United States
Allergy Assocaites Research Center — Portland, Oregon, United States
Valley Clinical Research Center — Bethlehem, Pennsylvania, United States
Asthma and Allergy Research Associates — Upland, Pennsylvania, United States
National Allergy, Asthma & Uticaria Centers of Charleston, P.A. — Charleston, South Carolina, United States
Isis Clinical Research, LLC — Austin, Texas, United States
Sirius Clinical Research LLC — Austin, Texas, United States
Pharmaceutical Research and Consulting Inc. — Dallas, Texas, United States
Kerrville Research Associates, PA — Kerrville, Texas, United States
Central Texas Health Research — New Braunfels, Texas, United States
Biogenics Research Institute — San Antonio, Texas, United States
Sylvana Research Associates — San Antonio, Texas, United States
ASTHMA Inc. Clinical Research Center — Seattle, Washington, United States
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

Full record on ClinicalTrials.gov

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