A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

Inclusion Criteria:

• Give written informed consent and assent, including privacy authorization as well asadherence to concomitant medication withholding periods, prior to participation.

• Subject must be in general good health based on screening physical examination,medical history, and clinical laboratory values.

• If any of the Screening visit Hematology, Chemistries, or Urinalysis are not withinthe clinical laboratory's reference range, then the subject can be included only ifthe Investigator judges the deviations to be not clinically significant.

• A history of PAR to a relevant perennial allergen (house dust mites, cockroach, molds,animal dander) for a minimum of two years immediately preceding the study Screeningvisit. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and require treatment throughout theentire study period.

• A demonstrated sensitivity at the Screening visit to at least one allergen known toinduce PAR (house dust mite, animal dander, cockroach, and molds) using a standardskin-prick test. The subject's positive allergen test must be consistent with themedical history of PAR and must be present in the subject's environment throughout thestudy.

• Based upon subject's medical history, in the Investigator's judgment, the subject isunlikely to have a seasonal exacerbation during the first 6 weeks of double-blindtreatment.

• 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.

Exclusion Criteria:

• Female subject who is pregnant or lactating.

• History of physical findings of nasal pathology, including nasal polyps or otherclinically significant respiratory tract malformations; recent nasal biopsy; nasaltrauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitismedicamentosa are not permitted within the last 60 days prior to the Screening visit.

• Subject is, in the investigator's judgement, having a seasonal exacerbation at thetime of screening.

• 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 and/orroutine use of beta agonists and any controller drugs (eg, theophylline, leukotrieneantagonists, etc.); intermittent use (less than or equal to 3 uses per week) ofinhaled short acting beta-agonists is acceptable. Use of short acting beta-agonistsfor exercise-induced bronchospasm will be allowed.

• Expected use of any disallowed concomitant medications during the treatment period.

• Initiation of immunotherapy during the study period or dose escalation during thestudy period. However, initiation of immunotherapy 90 days or more prior to theScreening Visit and use of a stable (maintenance) dose (30 days or more) may beconsidered for inclusion.

• Previous participation in an intranasal ciclesonide HFA nasal aerosol study.

• 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.

• Study participation by clinical investigator site employees and/or their immediaterelatives who reside in the same household.

• Study participation by more than one subject from the same household.

• 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

• history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts

• any systemic infection

• hematological, hepatic, renal, endocrine (except for controlled diabetes mellitusor postmenopausal symptoms or hypothyroidism)

• gastrointestinal disease

• malignancy (excluding basal cell carcinoma)

• current neuropsychological condition with or without drug therapy • Any conditionthat, in the judgment of the investigator, would preclude the subject fromcompleting the protocol with capture of the assessments as written.