Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Fluticasone propionate; Flonase®; Placebo
Intervention description: 50 mcg/actuation Nasal Spray; 50 mcg/actuation Nasal Spray; Inactive Nasal Spray
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1474.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Bioequivalence; Allergic Rhinitis

Summary:

      This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been
      designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray,
      50 mcg (Teva Pharmaceuticals USA) to the FDA Reference Listed Drug, Flonase® (fluticasone
      propionate) 50 mcg nasal spray (GlaxoSmithKline), in the relief of the signs and symptoms of
      Seasonal Allergic Rhinitis. Additionally, both the test and reference formulations will be
      tested for superiority against a placebo nasal spray.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating female 12 years or age or older.

          -  Signed informed consent form, which meets all criteria of current FDA regulations. For
             patients under the age of majority in the state the study is being conducted (18 years
             in most states) the parent or legal guardian should sign the consent form and the
             child will be required to sign a patient "assent" form that will be written in such a
             way as to be understandable to a child.

          -  If female and of child-bearing potential, have a negative urine pregnancy test and is
             prepared to abstain from sexual intercourse or use a reliable method of contraception
             during the study. In order for hormonal birth control to be considered a reliable
             method the patient must have been on their regimen for at least 28 days.

          -  Documented positive allergic skin test, performed within the previous 12 months, to
             one or more of the allergens in season at the time the study is being conducted.

          -  A minimum of two consecutive years of previous history of seasonal allergic rhinitis
             to the pollen/allergen in season at the time the study is being conducted.

          -  A score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) and a
             minimum score of at least 2 for "nasal congestion" and a minimum score of at least 2
             for one of the remaining 3 symptoms representing the 12 hours prior to the screening
             visit.

          -  An average composite score of at least 6 on the reflective Total Nasal Symptom Score
             (rTNSS) and a minimum score of at least 2 for "nasal congestion" and a minimum score
             of at least 2 for one of the remaining 3 symptoms representing the last 3 days of the
             7-day lead-in period before the randomization visit and the morning of the first day
             of the randomization visit.

        Exclusion Criteria:

          -  Under 12 years of age.

          -  Females who are pregnant, lactating, or likely to become pregnant during the study.

          -  Negative or lack of documented skin allergen test (performed within the previous 12
             months) to at least one of the allergens in season at the time of the study is being
             conducted. The results of all positive shin allergen tests should be reported.

          -  Patients who suffer from chronic signs and symptoms of perennial allergic rhinitis
             (PAR) should be excluded from the study unless the Investigator assesses that the
             patient's current signs and symptoms are a clear exacerbation of Seasonal Allergic
             Rhinitis (SAR) rather than chronic PAR.

          -  Patients who suffer only from perennial allergic rhinitis or seasonal allergic
             rhinitis to a different allergen that that in season at the time the study is
             conducted.

          -  Previous history of less than 2 years of seasonal allergic rhinitis to the
             pollen/allergen in season at the time the study is being conducted.

          -  A total score of less that 6 on the reflective Total Nasal Symptom Score (rTNSS) or a
             score of less than 2 for "nasal congestion" or a score of less than 2 for all 3 of the
             remaining symptoms.

          -  History of asthma over the previous 2 years that required chronic therapy. Occasional
             acute or mild exercise induced asthma will be allowable on the condition that the
             treatment of the attacks is restricted to beta-agonists only.

          -  Patients with nasal conditions, including infectious rhinitis, rhinitis medicamentosa,
             or atrophic rhinitis.

          -  Clinically significant nasal deformity (e.g. significantly deformed septum, nasal
             polyps, or ulcers) or any recent nasal surgery or trauma that has not completely
             healed.

          -  Sinus infection within the previous 30 days or history of re-occuring sinus
             infections.

          -  Patient has started immunotherapy (including topical or desensitization therapy) or
             changed their dose of immunotherapy within 30 days of the first dose, or is likely to
             have to start immunotherapy, or change their current dose during the study.

          -  Treatment for oral Candidiasis within 30 days of starting the study or a current
             Candidiasis infection.

          -  Upper respiratory tract infection within the previous 30 days.

          -  Patients with a history of tuberculosis.

          -  Patients with the presence of glaucoma, cataracts, ocular herpes simplex,
             conjunctivitis, or other eye infection not related to the diagnosis of SAR within 14
             days of enrollment.

          -  The patient has had recent exposure (30 days) or was at risk of being exposed to
             chicken pox or measles.

          -  Patients with any untreated fungal, bacterial, or systemic viral infections within the
             previous 30 days.

          -  Use of any ophthalmic steroids within 14 days or nasal, inhaled, or systemic steroids
             within 30 days of the study start.

          -  Use of medications that significantly inhibit the cytochrome P450 subfamily enzyme
             CYP3A4.

          -  Use of intranasal or systemic second-generation anti-histamines within 10 days of
             enrollment.

          -  Use of intranasal cromolyn within 14 days of enrollment.

          -  Use of intranasal or systemic first-generation anti-histamines, leukotriene receptor
             antagonists or other nasal decongestants within 3 days of enrollment.

          -  Use of any tricyclic anti-depressant within 30 days of enrollment.

          -  Patients with attention-deficit disorder being treated with methylphenidate containing
             products that have not been on a stable dosing regimen for at least the 30 previous
             days and who cannot remain on the same dosing regimen throughout the study.

          -  Desensitization therapy to the seasonal allergen that is causing the patients allergic
             rhinitis within the previous 6 months.

          -  Previous SAR and/or PAR that has proven unresponsive to steroid therapy.

          -  Any known hypersensitivity to fluticasone, other steroids, or any of the components of
             the study nasal sprays.

          -  Significant history or current evidence of chronic infectious disease, system
             disorder, organ disorder, or other medical condition that in the Investigator's
             opinion would place the study patient at undue risk by participating, or could
             jeopardize the integrity of the study evaluations.

          -  Receipt of any drug as part of a research study within 30 days prior to the first
             dose.

          -  Planned travel outside of the local area for more than 2 consecutive days or 3 days in
             total, during the patient's participation in the study.

          -  Previous participation in this study.

          -  The patient has a history or non-compliance with medical regimens or treatment
             protocols in previous clinical studies.

          -  The patient is a member of the investigational study staff or a member of the family
             of the investigational study staff.

          -  The patient currently smokes cigarettes, cigars, and/or pipes and is a heavy smoker
             (for example, on average more than 10 cigarettes per day).