A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Perennial (Year-round) Allergic Rhinitis

Inclusion Criteria

Subjects eligible for enrollment in the study must meet all of the following criteria:

• Informed consent
• Subject has provided an appropriately signed and dated informed consent.
• An appropriately signed and dated assent must be obtained from the parents or guardian if the subject is a child under 18 years of age.
• Outpatient
• Subject is treatable on an outpatient basis.
• Age
• ≥ 12 years at Visit 2
• ≥ 18 years at Visit 1 for Russia and Germany
• Male or eligible female. Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test will be performed for all females of childbearing potential at Visits 1, 2, 5, and Visit 6/Early Withdrawal to determine if the subject is pregnant.

To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following:

• Abstinence Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days).
• Oral contraceptive (either combined estrogen/progestin or progestin only),
• Injectable progestogen,
• Implants of levonorgestrel,
• Percutaneous contraceptive patches,
• Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year,
• Male partner who is sterile (vasectomy with documentation of azospermia) prior to the female subject's entry into the study and is the sole sexual partner for that female subject,
• Double barrier method-condom or occlusive cap (diaphragm or cervical /vault caps) plus spermicide,
• Estrogenic vaginal ring
• Diagnosis of PAR to include:
• A positive skin test (by prick method) response to appropriate perennial allergen (house dust mites, animal dander, mold, or cockroach) within last 12 months prior to Visit 1 or at Visit 1.

A positive skin test is defined as a wheal ≥3mm larger than the diluent control for prick testing.

• Two year medical history and past treatment of PAR (written or verbal confirmation) which includes perennial, i.e., year-round, symptoms. PAR symptoms would include nasal congestion, rhinorrhea, nasal itching and sneezing, eye itching/burning, eye tearing/watering, and eye redness.

In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed for the diagnosis of PAR.

NOTE: Subjects who meet the above criteria for PAR and who also have a history of allergy to a seasonal pollen that will be present in their geographic area during study participation are NOT eligible for randomization.

• Environment
• Subject must be symptomatic to appropriate perennial allergen (animal dander, house dust mites, cockroach, mold) and willing to maintain same environment throughout the study.
• Ability to comply with study procedures
• Subject understands and is willing, able and likely to comply with study procedures and restrictions.
• Literate
• Subject must be able to read, comprehend, and record information in English or native language.

Randomization Criteria

At Visit 2, the subject must meet the following criteria:

• Average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the four 24-hours periods prior to randomization must be ≥6. This includes the AM assessment on the morning of the randomization visit.
• Average of the last 8 reflective nasal symptom assessments for congestion (4 AM assessments, 4 PM assessments) over the four 24-hour periods prior to randomization must be ≥2. This includes the AM assessment on the morning of the randomization visit.
• Average of the last eight rTOSS assessments (4 AM assessments, 4 PM assessments) over the four 24-hour periods prior to randomization must be ≥ 4. This includes the AM assessment on th