Phase
Condition
Allergy
Rhinitis, Allergic, Perennial
Common Cold
Treatment
N/AClinical Study ID
Ages > 12 All Genders
Study Summary
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:
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 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
Study Description
Connect with a study center
Allergy & Asthma Associates of Southern California
Mission Viejo, California 92691
United StatesSite Not Available
CHOC PSF AMC - Division of Allergy, Asthma and Immunology
Orange, California 92868
United StatesSite Not Available
Allergy Associates Medical Group Inc.
San Diego, California 92120
United StatesSite Not Available
Bensch Research Associates
Stockton, California 95207
United StatesSite Not Available
Storms Clinical Research Institute
Colorado Springs, Colorado 80907
United StatesSite Not Available
DataQuest Medical Research LLC
Lawerenceville, Georgia 30046
United StatesSite Not Available
Asthma & Allergy Consultants, PC
Lilburn, Georgia 30047
United StatesSite Not Available
Gordon D Raphael, MD
Bethesda, Maryland 20814
United StatesSite Not Available
Medical Education and Research Management Services of New England
Gardner, Massachusetts 01440
United StatesSite Not Available
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts 02747
United StatesSite Not Available
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan 48197
United StatesSite Not Available
Clinical Research Institute Inc.
Minneappolis, Minnesota 55402
United StatesSite Not Available
The Clinical Research Center, LLC
St. Louis, Missouri 63141
United StatesSite Not Available
Clinical Research Group of Montanta
Bozeman, Montana 59718
United StatesSite Not Available
Ocean Allergy & Respiratory Research Center
Brick, New Jersey 08724
United StatesSite Not Available
Atlantic Research Center, LLC
Ocean, New Jersey 07721
United StatesSite Not Available
Princeton Center for Clinical Research
Skillman, New Jersey 08558
United StatesSite Not Available
Allergy and Asthma Center of NC, PA
High Point, North Carolina 27262
United StatesSite Not Available
North Carolina Clinical Research
Raleigh, North Carolina 27607
United StatesSite Not Available
Allergy Assocaites Research Center
Portland, Oregon 97202
United StatesSite Not Available
Valley Clinical Research Center
Bethlehem, Pennsylvania 18020
United StatesSite Not Available
Asthma and Allergy Research Associates
Upland, Pennsylvania 19013
United StatesSite Not Available
National Allergy, Asthma & Uticaria Centers of Charleston, P.A.
Charleston, South Carolina 29406
United StatesSite Not Available
Isis Clinical Research, LLC
Austin, Texas 78731
United StatesSite Not Available
Sirius Clinical Research LLC
Austin, Texas 78759
United StatesSite Not Available
Pharmaceutical Research and Consulting Inc.
Dallas, Texas 75231
United StatesSite Not Available
Kerrville Research Associates, PA
Kerrville, Texas 78028
United StatesSite Not Available
Central Texas Health Research
New Braunfels, Texas 78130
United StatesSite Not Available
Biogenics Research Institute
San Antonio, Texas 78229
United StatesSite Not Available
Sylvana Research Associates
San Antonio, Texas 78229
United StatesSite Not Available
ASTHMA Inc. Clinical Research Center
Seattle, Washington 98115
United StatesSite Not Available
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