Comparator Study Evaluating Patient Experience And Preference Of FFNS vs. FPNS
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: FPNS; FFNS; placebo FFNS; placebo FPNS
Intervention description: fluticasone propionate nasal spray; fluticasone furoate nasal spray; placebo nasal spray matching fluticasone furoate nasal spray; placebo nasal spray matching fluticasone propionate nasal spray
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: experience; GW685698X; fluticasone furoate; preference; seasonal allergic rhinitis; fluticasone propionate

Summary:

      The purpose of this replicate study to FFU105924 is to provide data on subject preference of
      FFNS as compared with FPNS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent

          -  Subject has provided an appropriately signed and dated informed consent.

          -  Otherwise healthy outpatient with fall allergy

          -  Subject is treatable on an outpatient basis.

          -  Age

          -  18 years or age or older at time of Visit 2

          -  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 required of all females at all
             visits 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 azoospermia) 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 SAR

          -  SAR is defined as follows:

          -  A clinical history (written or verbal) of SAR with seasonal allergy symptoms (nasal
             symptoms) during each of the last two fall allergy seasons, and

          -  A positive skin test (by prick method) to fall allergen prevalent to the geographic
             area during the conduct of the study, within 12 months prior to Visit 1 or at Visit 1.

          -  A positive skin test is defined as a wheal 3 mm larger than the diluent control for
             prick testing.

          -  In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed as a
             diagnosis of SAR.

          -  Subjects who meet the above criteria and who may also have perennial allergic rhinitis
             or vasomotor rhinitis are eligible for randomization.

          -  Adequate exposure to seasonal pollen

          -  Subject resides within a geographical region where exposure to fall seasonal allergen
             is expected to be significant during the entire study period.

          -  Subject does not plan to travel outside this area for more than 48 hours of the study
             period.

          -  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.

        Exclusion Criteria:

          -  Recent use (less than 1 year) of using branded (FLONASE) or generic FPNS or use of
             FFNS (VERAMYST).

          -  Significant concomitant medical conditions, defined as but not limited to:

          -  A historical or current evidence of clinically significant uncontrolled disease of any
             body system (e.g., tuberculosis, psychological disorders, eczema). 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 (eg, nasal septum) injury or surgery in the last 3 months

          -  Asthma, with the exception of mild intermittent asthma [National Asthma Education and
             Prevention Program (NARPP) Guidelines, 2002].

          -  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 participate safely and fully 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

          -  History of shingles

          -  Chickenpox or measles: A subject is not eligible if he/she currently has chickenpox or
             measles, or has been exposed to chickenpox or measles during the last 3 weeks and is
             non-immune. If a subject develops chickenpox or measles during the study, he/she will
             be withdrawn from the study. If a non-immune subject is exposed to chickenpox or
             measles during the study, his/her continuation in the study will be at the discretion
             of the investigator, taking into consideration the likelihood of developing active
             disease.

          -  Use of other corticosteroids, defined as:

          -  Intranasal corticosteroid within four weeks prior to Visit 1.

          -  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.

          -  Use of other allergy medications within the timeframe indicated relative to Visit 1

          -  Intranasal cromolyn within 14 days prior to Visit 1

          -  Short-acting prescription and OTC antihistamines, including antihistamines contained
             in insomnia and 'nighttime' pain formulations taken for insomnia, within 3 days prior
             to Visit 1

          -  Long-acting antihistamines within 10 days prior to Visit 1: loratadine, desloratadine,
             fexofenadine, cetirizine

          -  Oral or intranasal decongestants within 3 days prior to Visit 1

          -  Intranasal, oral, or inhaled anticholinergics within 3 days prior to Visit 1

          -  Oral antileukotrienes within 3 days prior to Visit 1

          -  Subcutaneous omalizumab (Xolair) within 5 months of Visit 1

          -  Intranasal antihistamines (e.g. Astelin) within 2 weeks prior to Visit 1

          -  Use of other medications that may affect allergic rhinitis or its symptoms

          -  Chronic use of concomitant medications, such as tricyclic antidepressants, that would
             affect assessment of the effectiveness of the study drug

          -  Chronic use of long-acting beta-agonists (e.g., salmeterol)

          -  Chronic use of other intranasally administered medications (e.g., calcitonin-salmon)

          -  Nasal irrigation solutions

          -  Use of immunosuppressive medications 8 weeks prior to screening and during the study

          -  Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme
             CYP3A4, including ritonavir and ketoconazole

          -  Immunotherapy

          -  Subjects may be enrolled into the study if the immunotherapy was not initiated within
             30 days of Visit 1, 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.

          -  Allergy/Intolerance

          -  Known hypersensitivity to corticosteroids or any excipients in the product

          -  Clinical trial/experimental medication experience

          -  Has recent exposure to an investigational study drug within 30 days of Visit 1

          -  Participation in a previous or current GSK FFNS study

          -  Positive or inconclusive pregnancy test or female who is breastfeeding

          -  Has a positive or inconclusive pregnancy test at Visit 1 or Visit 2

          -  Affiliation with investigational site

          -  Subject is a participating investigator, sub-investigator, study co-ordinator, or
             employee of a participating investigator, or is an immediate family member of the
             aforementioned.

          -  Current tobacco use

          -  Subject currently uses smoking products including cigarettes, cigars, and pipe or
             chewing tobacco.