To assess the safety of Ciclesonide, applied as a nasal spray at three dose levels, in the treatment of perennial allergic rhinitis in pediatrics (BY9010/M1-405)

Exclusion Criteria

• 1. History of physical findings of nasal pathology, including nasal polyps
• (within the last 60 days) or other clinically significant respiratory tract
• malformations, recent nasal biopsy (within the last 60 days), nasal trauma,
• or surgery and atrophic rhinitis or rhinitis medicamentosa (within the last
• 60 days).
• 2. Participation in any investigational drug trial within the 30 days preceding
• the Screening Visit (B0) or at any time during the trial
• 3. A known hypersensitivity to any corticosteroid or any of the excipients in
• the formulation.
• 4. History of a respiratory infection or disorder [including, but not limited
• to bronchitis, pneumonia, the common cold, acute or chronic sinusitis, flu,
• severe acute respiratory syndrome (SARS)] within the 14 days preceding the
• Screening Visit, or development of a respiratory infection during the
• Screening Visit (B0)
• 5. History of a positive test for HIV, hepatitis B or hepatitis C.
• 6. Active asthma requiring treatment with inhaled or systemic corticosteroids
• and/or routine use of b-agonists and any controller drugs (e.g.
• theophylline, leukotrienes, etc.) intermittent use of b-agonists is
• acceptable
• 7. Use of any prohibited concomitant medications within the prescribed (per
• protocol) withdrawal periods prior to the screening visit (B0) and during
• the entire screening period and treatment duration
• 8. Use of antibiotic therapy for acute conditions within 14 days prior to the
• Screening Visit (B0).
• 9. 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.
• 10. Non-vaccinated exposure to, or infection with, chickenpox or measles
• within the 21 days preceding the Screening Visit (B0).
• 11. Exposure to systemic corticosteroids for any indication, chronic or
• intermittent (e.g.: contact dermatitis), during the past 2 months, or
• presence of an underlying condition that can reasonably be expected to
• require treatment with corticosteroids during the course of the study.
• 12. Use of topical corticosteroids in concentrations in excess of 1%
• hydrocortisone for dermatological conditions during the past 1 month, or
• presence of an underlying condition that can reasonably be expected to
• require treatment with such preparations during the course of the study.
• 13.Intraocular pressure at the screening visit (B0) of 21 mm Hg or greater or
• failed reading at the screening Visit (B0)
• 14. Glaucoma requiring treatment
• 15. Use of antiepileptic drugs for epilepsy within 30 days of the screening
• visit (B0) or anytime during the treatment period.
• 16. Initiation of pimecrolimus 1% cream or tacrolimus ointment 0.1% or 0.03% during the study period or planned dose escalation during the study period. However, initiation of these creams/ointments 30 days or more prior to the screening Visit (B0) AND use of a stable (maintenance) dose during the study period may be considered for inclusion