Clinical Trial to Assess the Efficacy and Safety of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis

Inclusion Criteria

• Give written informed consent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
• Male or female 12 years and older, as of the Screening Visit (Visit 1).
• Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, medical history, and clinical laboratory values (Hematology, Chemistries and Urinalysis).
• A history of SAR to Mountain Cedar for a minimum of two years immediately preceding the study Screening Visit (Visit 1). The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the Investigator's judgment (through exposure to allergen) is expected to require treatment throughout the entire study period.
• A demonstrated sensitivity to Mountain Cedar known to induce SAR through a standard skin prick test administered at Visit 1 (screening). A positive test is defined as a wheal diameter at least 5 mm larger than the control wheal (normal saline) for the skin prick test.
• Subject, if female 65 years of age or younger, must have a negative serum pregnancy test (performed at Visit 1) prior to randomization at Visit 2. Women of childbearing potential (excluding females at least two years postmenopausal or surgically sterile) must sign the Women of Childbearing Potential Addendum to the informed consent form. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:
• An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study and will continue its use throughout the study and for thirty days following study participation.
• Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
• Abstinence.
• Subject or parent/guardian must possess an educational level and degree of understanding of English that enables them to communicate suitably with the Investigator and study coordinator as well as accurately complete both the AR diary and RQLQ(S).

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; nasal ulcers or perforations; or surgery and atrophic rhinitis or rhinitis medicamentosa (all within the last 60 days prior to the Screening Visit).
• Participation in any investigational drug trial within the 30 days preceding the Screening Visit (Visit 1) 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, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit (Visit 1).
• History of alcohol or drug abuse (or a positive urine drug screen at Visit 1) within two years preceding the Screening Visit.
• History of a positive test for HIV, hepatitis B or hepatitis C.
• Plans to travel outside the study area (the known pollen area for the investigative site) for more than 24 hours during the Run in period.
• Plans to travel outside the study area (the known pollen area for the investigative site) for 2 or more consecutive days between Randomization Visit (Visit 3) and the final Treatment Visit (Visit 5).
• Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta agonists and any controller drugs (e.g., theophylline, leukotriene antagonists, etc.); intermittent