Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy (BY9010/M1-490)

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 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).
• •3. Participation in any investigational drug trial within the 30 days preceding the Screening Visit.
• •4. A known hypersensitivity to any intranasal corticosteroid, antihistamine 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. 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.
• •10. 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.
• •11. 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.
• •12. Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit (B0).
• •13. 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.
• •14. 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.
• •15. History of epilepsy or seizures (excluding febrile seizures).
• •16. History of coronary artery disease, uncontrolled hypertension, or other clinically significant cardiovascular disease.
• •17. Patients using combination treatment for allergic rhinitis (e.g. intranasal corticosteroid and antihistamine).
• •18. Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult:
• •* Impaired hepatic function including alcohol-related liver disease or cirrhosis;
• •* History of ocular disturbances e.g. glaucoma or posterior subcapsular cataracts;
• •* Any systemic infection;
• •* Hematological, hepatic, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism);· Gastrointestinal disease;
• •* Malignancy (excluding basal cell carcinoma).
• •19. Clinical site employees and their immediate relatives are excluded from study participation.