To assess the safety and efficacy of Ciclesonide, applied as a nasal spray in the treatment of seasonal allergic rhinitis (BY9010/M1-401)

Exclusion Criteria

• 1. Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or
• sperm) for in vitro fertilization during the study period or for 30 days
• following the study period.
• 2. History or 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).
• 3. Participation in any investigational drug trial within the 30 days preceding
• the Screening Visit.
• 4. A known hypersensitivity to any corticosteroid or any of the excipients in
• the formulation.
• 5. 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 Period.
• 6. History of alcohol or drug abuse within the preceding two years.
• 7. History of a positive test for HIV, hepatitis B or hepatitis C.
• 8. Active asthma requiring treatment with inhaled or systemic corticosteroids
• and/or routine use of b-agonists; intermittent use of b-agonists is
• acceptable.
• 9. Plans to travel outside the study area (the known pollen area for the
• investigative site) for two or more consecutive days OR 5 or more days total
• during the 5-week study period ( Baseline and Treatment Periods).
• 10.Use of any prohibited concomitant medications within the prescribed (per
• protocol) time since last dose period prior to the Screening Visit (B0) and
• during entire treatment duration.
• 11.Use of antibiotic therapy for acute conditions within 14 days prior to the
• Screening Visit (B0). Low doses of antibiotics taken for prophylaxis are
• permitted if the therapy was started prior to the Screening Visit AND is
• expected to continue throughout the trial.
• 12.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.
• 13.Previous participation in an intranasal ciclesonide study.
• 14.Non-vaccinated exposure to or active infection with, chickenpox or measles
• within the 21 days preceding the Screening Visit (B0).
• 15.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.
• 16.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.