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

Exclusion Criteria

• •Has a history of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent unhealed nasal biopsy; nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the 120 days prior to the screening visit.
• •Has evidence of infection, significant anatomic abnormality, ulceration of the mucosa, blood in the nose, or any other clinically relevant finding on nasal examination at the screening visit.
• •Has nasal jewelry
• •Has participated in any investigational drug trial within the 30 days preceding the screening visit or is planning participation in another investigational drug trial at any time during this trial.
• •Has a known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
• •Has a history of a respiratory infection or disorder, including but not limited to bronchitis, pneumonia, influenza, and severe acute respiratory syndrome (SARS), within the 14 days preceding the screening visit.
• •Has active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drugs (eg, theophylline, leukotriene antagonists); intermittent use (≤ 3 uses per week) of inhaled short-acting beta-agonists is acceptable. Use of short-acting beta agonists for exercise induced bronchospasm will be allowed.
• •Plans to travel outside the study area (the known pollen area for the investigative site) for 2 or more consecutive days between Randomization Visit and the final Treatment Visit.
• •Plans to leave the study area (the known pollen area for the investigative site) for longer than 24 hours during the Single-blind Placebo Run-in period.
• •Is expecting to use any disallowed concomitant medications during the treatment period.
• •Is planning initiation of immunotherapy during the study period or dose escalation during the study period. However, initiation of immunotherapy 90 days or more prior to the screening visit and use of a stable (maintenance) dose (30 days or more) may be considered for inclusion.
• •Has nonvaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the screening visit.
• •Initiates pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during 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 a stable (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 who are not directly involved in this study.
• •Has any of the following conditions that are judged by the investigator to be clinically significant and/or to affect the subject's ability to participate in the clinical trial: impaired hepatic function; history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts or 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 behavioral condition that could affect subject's ability to accurately report symptoms to the caregiver such as developmental delay, attention deficit disorder, and autism.
• •Has any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written.
• •Has received ciclesonide nasal aerosol in a previous clinical trial