A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis

Exclusion Criteria

• •Subjects should not have travelled outside the local pollen region for more than 48 hours during the run-in period.
• •Significant concomitant medical conditions, defined as but not limited to:
• •Historical or current evidence of a clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema, uncontrolled asthma). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study.
• •A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of intranasal study drug.
• •Nasal (e.g., nasal septum), ocular, or throat injury, or surgery to these areas in the last 3 months.
• •Rhinitis medicamentosa. Bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory tract within two weeks of Visit 1 or during the screening period.
• •Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator.
• •Current or history of glaucoma and/or cataracts or ocular herpes simplex. Physical impairment that would affect subject's ability to safely and fully participate in the study.
• •Clinical evidence of a Candida infection of the nose. History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would confound the interpretation of the study results.
• •History of adrenal insufficiency.
• •Use of corticosteroids, defined as: Intranasal corticosteroid within four weeks prior to Visit 1 and during the treatment period. Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1 and during the treatment period.
• •Use of allergy medications, within a timeframe relative to Visit 1, that would prevent the medication from being eliminated and/or have an effect. Exclusionary timeframes relative to Visit 1 for five common allergy treatments are noted below Intranasal cromolyn (\<=2 weeks from Visit 1). Intranasal or systemic decongestants (\<=3 days from Visit 1). Intranasal or systemic (other than oral) antihistamines (\<=3 days from Visit 1).
• •Leukotriene modifiers (\<=3 days from Visit 1). Oral antihistamines (\<=2 days from Visit 1). Allergy medications, other than study supplied medications, are not allowed during the study.
• •Use of other medications that may affect allergic rhinitis or its symptoms, e.g., use of any ocular antihistamines, artificial tears, eyewashes/nasal irrigation solutions, homeopathic preparations, lubricants, sympathomimetic or vasoconstrictor preparations during the screening and treatment periods
• •Use of any medications (prescription or non-prescription) or alcohol to induce sleep 48-hours prior to Visit 1 and during the treatment period.
• •Use of other intranasally administered medications (e.g., calcitonin), including herbals and homeopathics during the run-in (Visit 1 - Visit 2) and treatment period.
• •Use of immunosuppressive medications within 8 weeks prior to screening and during the treatment period.
• •Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4 (e.g., ritonavir, ketoconazole) during the run-in (Visit 1 - Visit 2) and treatment period.
• •Known hypersensitivity to corticosteroids or any excipients present in the nasal spray.
• •Known hypersensitivity to cetirizine or any excipients in the tablet.
• •Recent exposure to an investigational study drug or device within 30 days of Visit 1.
• •Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.
• •Chickenpox or measles during the last 3 weeks prior to screening and is non-immune.
• •Immunotherapy is exclusionary unless the immunotherapy was initiated \>=30 days from Visit 1 and if the dose has remained fixed over the 30 days prior to Visit 1, and the dose will remain fixed for the duration of the study.
• •Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirement.