Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray when Administered Concomitantly with Orally Inhaled Beclomethasone Dipropionate (HFA-BDP) in Patients with Perennial Allergic Rhinitis (PAR) (BY9010/M1-408)

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 (S0).
• 4. A known hypersensitivity to any corticosteroid or any of the excipients in
• the formulations.
• 5. History or current evidence of clinically relevant allergies or idiosyncrasy
• to drugs or food.
• 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. Use of any prohibited concomitant medications within the prescribed (per
• protocol) withdrawal periods prior to the Screening Visit (S0) and during
• entire study duration.
• 9. Previous participation in an intranasal ciclesonide study.
• 10. Non-vaccinated exposure to or active infection with, chickenpox or measles
• within the 21 days preceding the Screening Visit (S0).
• 11. Exposure to corticosteroids for any indication, chronic or intermittent
• (e.g.: asthma, 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 the
• equivalent 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. Clinically relevant abnormalities in clinical chemical, hematological or
• any other laboratory variables.
• 14. Chronic or clinically relevant acute infections.
• 15. Vegetarian diet or other unusual dietary habits that would preclude the
• subject's acceptance of standardized meals.
• 16. Blood donation within the last 30 days before start of the study.
• 17. Patients that do not have regular sleep patterns (e.g. working at night and
• sleeping during the daylight hours).
• 18. Active asthma requiring treatment with inhaled or systemic corticosteroids;
• intermittent use of beta agonists is acceptable.
• 19. 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 (S0), or development of a respiratory infection during the
• Run-in Period.
• 20. Use of antibiotic therapy for acute conditions within 14 days prior to the
• Screening Visit (S0). Low doses of antibiotics taken for prophylaxis are
• permitted if the therapy was started prior to the Screening Visit (S0) AND
• is expected to continue throughout the trial.
• 21. 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 (S0) AND use of a stable (maintenance)
• dose (30 days or more) may be considered for inclusion.
• 22. Failure to adequately understand and comply with the HFA-BDP instructions
• or failure to properly administer study medication.