Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis

Exclusion Criteria

• •Female subject who is pregnant or lactating.
• •History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 120 days prior to the Screening visit.
• •Subject is, in the investigator's judgement, having a seasonal exacerbation at the time of screening.
• •Participation in any investigational drug trial within the 30 days preceding the Screening visit or planned participation in another investigational drug trial at any time during this trial.
• •A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
• •History of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, influenza, severe acute respiratory syndrome (SARS)\] within the 14 days preceding the Screening visit.
• •History of alcohol or drug abuse within 2 years preceding the Screening visit.
• •History of a positive test for HIV, hepatitis B or hepatitis C.
• •Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta agonists and any controller drugs (eg, theophylline, leukotriene antagonists, etc.); intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists is acceptable. Use of short acting beta-agonists for exercise-induced bronchospasm will be allowed.
• •Expected use of any disallowed concomitant medications during the treatment period.
• •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.
• •Previous randomization in an intranasal ciclesonide HFA nasal aerosol study.
• •Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit.
• •Initiation of pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during the study period or planned dose escalation during the study period. However, initiation of these creams/ointments 30 days or more prior to screening and use of a stable (maintenance) dose during the study period may be considered for inclusion.
• •Study participation by clinical investigator site employees and/or their immediate relatives who reside in the same household.
• •Study participation by more than one subject from the same household.
• •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, eg, 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); current neuropsychological condition with or without drug therapy
• •Any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written.