An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo

Inclusion criteria

• provide written informed consent and signed HIPAA form;
• be able and willing to follow all instructions and attend the study visits;
• if female and of childbearing potential, be not pregnant, nursing or planning a pregnancy, be willing to submit a pregnancy test at Visit 1 and at exit visit, and to use adequate method of birth control
• have a positive history of seasonal allergic rhinitis to ragweed;
• have a positive skin test reaction to ragweed of within the past 24 months;
• manifest sufficient allergic rhinitis symptoms during ragweed exposure in the ABC

Exclusion criteria

• known intolerance or allergy to antihistamines or corticosteroids;
• have a compromised lung function at Visit 1;
• develop a compromised lung function at Visits 2-6
• have any presence of active sinus or nasal infection at any visit;
• have experienced an acute upper or lower respiratory tract infection or acute sinusitis within 30 days of visit 1;
• have significant nasal anatomical deformities or any condition that does not allow subject to breathe through the nose (includes, but is not limited to: septal deviation, septal perforations, nasal polyps, rhinitis medicamentosa)
• have had any nasal surgical intervention in the past;
• have a known history of glaucoma
• have planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter;
• inability or refusal to discontinue contact lens wear during all visits;
• use disallowed medications during the study or appropriate pre-study washout period