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)

Last updated: July 23, 2014
Sponsor: Sunovion
Overall Status: Completed

Phase

4

Condition

Allergy

Rhinitis, Allergic, Perennial

Common Cold

Treatment

N/A

Clinical Study ID

NCT01654536
SEP060-401
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject or Subject's parent/guardian gives written informed consent and assent,including privacy authorization as well as adherence to concomitant medicationwithholding 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 clinicallyrelevant abnormalities as determined by the Investigator) based on screening physicalexamination, 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 studyScreening visit. The PAR must have been of sufficient severity to have requiredtreatment (either continuous or intermittent) in the past 12 months, and requiretreatment throughout the entire study period.

  • Subject, if female ≤ 65 years of age, must have a negative serum pregnancy test atscreening. Females of childbearing potential must be instructed to and agree to avoidpregnancy 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 enteringthe study with continued use throughout the study and for thirty days followingstudy participation.

  • Barrier method of contraception, eg, condom and/or diaphragm with spermicidewhile participating in the study.

  • Abstinence.

  • Subject must possess an educational level and degree of understanding of English thatenables them to communicate suitably with the PI and study coordinator.

Exclusion

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 andrandomization 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 notpermitted within the last 30 days prior to the Screening visit.

  • Participation in any investigational drug trial within the 30 days preceding theScreening visit or planned participation in another investigational drug trial at anytime during this trial.

  • A known hypersensitivity to any corticosteroid or any of the excipients in theformulation of ciclesonide.

  • History of a respiratory infection or disorder [including, but not limited tobronchitis, 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 greaterduring 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 astable (maintenance) dose during the study period may be considered for inclusion.

  • Use of nasal corticosteroids within 14 days, or ocular, oral or parenteral within 6months prior to randomization.

  • Have any of the following conditions that are judged by the investigator to beclinically significant and/or affect the subject's ability to participate in theclinical trial:

  1. impaired hepatic function including alcohol related liver disease or cirrhosis

  2. diabetes mellitus

  3. malignancy (excluding basal cell carcinoma)

  • Any condition that, in the judgment of the investigator, would preclude the subjectfrom completing the protocol with capture of the assessments as written OcularExclusion Criteria

  • History of bacterial or viral infection of the eyes within 14 days of the Screeningvisit or current or history of ocular herpes simplex.

  • Any use within 6 months prior to the randomization or planned use during the trial ofa topical ocular corticosteroid, or intraocular or periocular injection ofcorticosteroids.

  • Progressive retinal (including, but not limited to acute macular degeneration orunstable diabetic retinopathy) or optic nerve disease in either eye.

  • Ocular injury/surgery in the last 6 months (including LASIK eye surgery, as well asany 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.

  • Occludable angles by slit lamp examination (eg, peripheral anterior chamber less thanor equal to one quarter of the peripheral corneal thickness), which may be confirmedby gonioscopy at the investigator's discretion..

  • Current PSC cataract or previous history of cataract surgery.

  • Current or history of congenital cataract or active or prior uveitis.

  • Historical or current intraocular pressure of 22 mm Hg or higher in either eye.

  • Inability to complete ocular examination, including: Inability to measure intraocularpressure, Pupillary diameter < 6 mm upon dilation , Significant media opacity ineither eye that would exclude adequate posterior segment examination, Clinicallysignificant corneal dystrophy, epithelial, or endothelial disease that would precludevisualization or intraocular pressure measurement, Corneal irregularities or scarringthat in the investigator's judgment would impeded an accurate measurement ofintraocular pressure or visualization of intraocular anatomy, Unwillingness to removecontact lenses for ocular examination, Subjects with LOCS III grade NO > 4.0, NC > 4.0and C > 4.0 in either eye

  • Best-corrected visual acuity in either eye of 20/200 or worse at the screening ocularexamination.

  • Planned or anticipated ocular surgery during the next 6 months.

  • Any condition that, in the judgment of the ophthalmologist, would preclude the subjectfrom completing the protocol with capture of the assessments as written.

Study Design

Total Participants: 737
Study Start date:
September 01, 2012
Estimated Completion Date:
July 31, 2013

Study 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.

Connect with a study center

  • Allergy & Asthma Associates of Southern California

    Mission Viejo, California 92691
    United States

    Site Not Available

  • CHOC PSF AMC - Division of Allergy, Asthma and Immunology

    Orange, California 92868
    United States

    Site Not Available

  • Allergy Associates Medical Group Inc.

    San Diego, California 92120
    United States

    Site Not Available

  • Bensch Research Associates

    Stockton, California 95207
    United States

    Site Not Available

  • Storms Clinical Research Institute

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • DataQuest Medical Research LLC

    Lawerenceville, Georgia 30046
    United States

    Site Not Available

  • Asthma & Allergy Consultants, PC

    Lilburn, Georgia 30047
    United States

    Site Not Available

  • Gordon D Raphael, MD

    Bethesda, Maryland 20814
    United States

    Site Not Available

  • Medical Education and Research Management Services of New England

    Gardner, Massachusetts 01440
    United States

    Site Not Available

  • Northeast Medical Research Associates, Inc.

    North Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Clinical Research Institute Inc.

    Minneappolis, Minnesota 55402
    United States

    Site Not Available

  • The Clinical Research Center, LLC

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Clinical Research Group of Montanta

    Bozeman, Montana 59718
    United States

    Site Not Available

  • Ocean Allergy & Respiratory Research Center

    Brick, New Jersey 08724
    United States

    Site Not Available

  • Atlantic Research Center, LLC

    Ocean, New Jersey 07721
    United States

    Site Not Available

  • Princeton Center for Clinical Research

    Skillman, New Jersey 08558
    United States

    Site Not Available

  • Allergy and Asthma Center of NC, PA

    High Point, North Carolina 27262
    United States

    Site Not Available

  • North Carolina Clinical Research

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Allergy Assocaites Research Center

    Portland, Oregon 97202
    United States

    Site Not Available

  • Valley Clinical Research Center

    Bethlehem, Pennsylvania 18020
    United States

    Site Not Available

  • Asthma and Allergy Research Associates

    Upland, Pennsylvania 19013
    United States

    Site Not Available

  • National Allergy, Asthma & Uticaria Centers of Charleston, P.A.

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Isis Clinical Research, LLC

    Austin, Texas 78731
    United States

    Site Not Available

  • Sirius Clinical Research LLC

    Austin, Texas 78759
    United States

    Site Not Available

  • Pharmaceutical Research and Consulting Inc.

    Dallas, Texas 75231
    United States

    Site Not Available

  • Kerrville Research Associates, PA

    Kerrville, Texas 78028
    United States

    Site Not Available

  • Central Texas Health Research

    New Braunfels, Texas 78130
    United States

    Site Not Available

  • Biogenics Research Institute

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Sylvana Research Associates

    San Antonio, Texas 78229
    United States

    Site Not Available

  • ASTHMA Inc. Clinical Research Center

    Seattle, Washington 98115
    United States

    Site Not Available

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