A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).

Inclusion Criteria:

• Gives written informed consent (parent/legal guardian) and assent (from the child),including privacy authorization as well as adherence to concomitant medicationwithholding periods, prior to participation.

• Is a male or premenarchal female 6 to 11 years old at the screening visit.

• Is in general good health (defined as the absence of any clinically relevantabnormalities as determined by the investigator) based on screening physicalexamination and medical history.

• Has a history of PAR to a relevant perennial allergen (house dust mites, cockroaches,molds, and animal dander) for a minimum of 1 year immediately preceding the studyscreening visit. The PAR must have been of sufficient severity to have requiredtreatment (either continuous or intermittent) in the past and require treatmentthroughout the entire study period.

• Has a demonstrated sensitivity to at least 1 allergen known to induce PAR (house dustmites, cockroaches, molds, and animal dander) based on a documented result with astandard skin-prick test either within 12 months prior to screening visit or performedat the screening visit. A positive test is defined as a wheal diameter at least 3 mmlarger than the negative control wheal for the skin-prick test. The subject's positiveallergen test must be consistent with the medical history of PAR, and the allergenmust be present in the subject's environment throughout the study.

• Subject or parent/guardian must possess an educational level and degree ofunderstanding of English that enables them to communicate suitably with theInvestigator and study coordinator as well as accurately complete both the AR diaryand PRQLQ

Exclusion Criteria:

• Has a history of physical findings of nasal pathology, including nasal polyps or otherclinically significant respiratory tract malformations; recent unhealed nasal biopsy;nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis orrhinitis medicamentosa are not permitted within the 120 days prior to the screeningvisit.

• Has evidence of infection, significant anatomic abnormality, ulceration of the mucosa,blood in the nose, or any other clinically relevant finding on nasal examination atthe screening visit.

• Has nasal jewelry.

• Has participated in any investigational drug trial within the 30 days preceding thescreening visit or is planning participation in another investigational drug trial atany time during this trial.

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

• Has a history of a respiratory infection or disorder, including but not limited tobronchitis, pneumonia, influenza, and severe acute respiratory syndrome, within the 14days preceding the screening visit.

• Has active asthma requiring treatment with inhaled or systemic corticosteroids and/orroutine use of beta-agonists and any controller drugs (eg, theophylline, leukotrieneantagonists); intermittent use (≤ 3 uses per week) of inhaled short-actingbeta-agonists is acceptable. Use of short-acting beta-agonists for exercise-inducedbronchospasm will be allowed.

• Is expecting to use any disallowed concomitant medications during the treatmentperiod.

• Is, in the investigator's judgment, having a seasonal exacerbation at the time of thescreening visit or is likely to have one during the study.

• Is planning initiation of immunotherapy during the study period or dose escalationduring the study period. However, initiation of immunotherapy 90 days or more prior tothe screening visit and use of a stable (maintenance) dose (30 days or more) may beconsidered for inclusion.

• Has nonvaccinated exposure to or active infection with chickenpox or measles withinthe 21 days preceding the screening visit.

• Initiates pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greaterduring the study period or plans a 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.

• Is a child or relative of any clinical investigator or site personnel, even those whoare not directly involved in this study.

• Resides in the same household as another subject who is participating in this study.

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

• impaired hepatic function

• history of ocular disturbances, eg, glaucoma or posterior subcapsular cataractsor herpes simplex

• any systemic infection

• hematological (including anemia), hepatic, renal, endocrine disease

• gastrointestinal disease

• malignancy (excluding basal cell carcinoma)

• current neuropsychological condition with or without drug therapy. Any behavioralcondition that could affect the subject's ability to accurately report symptomsto the caregiver such as developmental delay, attention deficit disorder, andautism.

• Has any condition that, in the judgment of the investigator, would preclude thesubject from completing the protocol with the capture of the assessments as written.

• Has received ciclesonide nasal aerosol in a previous clinical trial.