Study using the environmental exposure unit (EEU) to assess the onset of action of ciclesonide, applied as a nasal spray in the treatment of seasonal allergic rhinitis (BY9010/M1-407)

Exclusion Criteria

• 1. Pregnancy, nursing, or donation of gametes (ova or sperm) for in vitro
• fertilization during the study period or plans to become pregnant or donate
• gametes (ova or sperm) for in vitro fertilization for 30 days following the
• study period. Females unwilling to employ appropriate contraceptive measures
• to ensure that pregnancy will not occur during the study will be
• excluded.
• 2. Have clinically significant physical findings of nasal anatomical
• deformities causing greater than 50% obstruction based upon the clinical
• estimate by the investigator, including nasal polyps, septal defects or
• other clinically significant respiratory tract malformations, recent nasal
• biopsy, nasal trauma, or nasal surgery and atrophic rhinitis or rhinitis
• medicamentosa (within the last 60 days prior to Screening Visit - B0).
• 3. Participation in any investigational drug trial within the 30 days preceding
• the Screening Visit (B0) and thereafter.
• 4. Known hypersensitivity to any corticosteroid or any of the excipients in the
• formulation.
• 5. History of severe respiratory infection or disorder [including, but not
• limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute
• respiratory syndrome (SARS)] within the 14 days preceding the Screening
• Visit (B0) and thereafter.
• 6. History of alcohol or drug abuse within the preceding two years from
• Screening Visit (B0).
• 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 or any controller drugs (e.g. theophylline,
• leukotriene antagonist); intermittent use (less than or equal to 3 uses per
• week) of inhaled short-acting b-agonists is acceptable.
• 9. Use of any prohibited concomitant medications within the prescribed (per
• protocol) exclusion periods (refer to Section 6.3 of the protocol).
• 10. Use of antibiotic therapy for acute conditions within 14 days prior to the
• Screening Visit (B0) and thereafter. Low doses of antibiotics taken for
• prophylaxis are permitted if the therapy was started prior to the Screening
• Visit (B0) AND is expected to continue through out the Baseline Period (B0
• to T0 Visit) and Treatment Visit (T0).
• 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 (B0) AND use of a stable (maintenance)
• dose (28 days or more prior to the Screening Visit (B0)) may be considered
• for inclusion provided no immunotherapy injections are received within 48
• hours prior to a ragweed pollen exposure visit.
• 12.Previous participation in an intranasal ciclesonide study.
• 13. Non-vaccinated exposure to or active infection with, chickenpox or measles
• within the 21 days preceding the Screening Visit (B0).
• 14. Exposure to systemic corticosteroids for any indication, chronic or
• intermittent (e.g., arthritis), during the past 60 days from Screening Visit
• (B0), or presence of an underlying condition that can reasonably be expected
• to require treatment with corticosteroids during the course of the study.
• 15. Use of topical corticosteroids in concentrations in excess of 1%
• hydrocortisone for dermatological conditions within 30 days prior to the
• Screening Visit (B0), or presence of an underlying condition that can
• reasonably be expected to require treatment with such preparations during
• the course of the study (B0 to T0 Visit, both visits inclusive).
• Hydrocortisone of less than or equal to 1% concentration covering less than
• or equal to 10% of the total body surface without occlusion is
• acceptable.
• 16. History of epilepsy or seizures (excluding febrile seizures).
• 17. History of coronary artery disease, uncontrolled hypertension, or other
• clinically significant cardiovascular disease.
• 18. History of malignancy (excluding basal cell carcinoma).
• 19. 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:
• · 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, renal, endocrine (except for controlled diabetes mellitus
• or postmenopausal symptoms or hypothyroidism);
• · Gastrointestinal disease;
• · A current neuropsychiatric condition with or without drug therapy.