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

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.

• 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 SAR to any relevant dominant seasonal allergen for a minimum of oneto two years immediately preceding the study Screening Visit. The SAR must have beenof sufficient severity to have required treatment (either continuous or intermittent)in the past and is expected to require treatment throughout the entire study period.

• Has a demonstrated sensitivity to a relevant dominant seasonal allergen known toinduce SAR based on a documented result with a standard skin prick test either within 12 months prior to screening or performed at the screening visit. A positive test isdefined as a wheal diameter at least 3 mm larger than the control wheal (normalsaline) for the skin prick test. The subject's positive allergen test must beconsistent with the medical history of SAR, and the allergen must be present in thesubject'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 AllergicRhinitis diary and Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (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 (SARS), withinthe 14 days 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.

• Plans to travel outside the study area (the known pollen area for the investigativesite) for 2 or more consecutive days between Randomization Visit and the finalTreatment Visit.

• Plans to leave the study area (the known pollen area for the investigative site) forlonger than 24 hours during the Single-blind Placebo Run-in period.

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

• 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.

• 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 cataracts or herpes simplex; any systemic infectionhematological (including anemia), hepatic, renal, endocrine disease; gastrointestinaldisease; malignancy (excluding basal cell carcinoma); current neuropsychologicalcondition with or without drug therapy. Any behavioral condition that could affectsubject's ability to accurately report symptoms to the caregiver such as developmentaldelay, attention deficit disorder, and autism.

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

• Has received ciclesonide nasal aerosol in a previous clinical trial