Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Fluticasone furoate nasal spray; Placebo nasal spray
Intervention description: Fluticasone furoate nasal spray 110mg QD; Placebo nasal spray
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 474.0
Sex: All
Minimum age: 5 Years
Maximum age: 8 Years
Healthy volunteers: No
Keywords: allergic rhinitis; fluticasone furoate nasal spray; growth

Summary:

      The primary objective of this study is to characterize, as accurately as possible, the
      estimation of the difference in pre-pubescent growth velocities between subjects treated
      continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in
      the US, and placebo nasal spray as determined by stadiometry.
    

Eligibility criteria:

        Inclusion criteria:

          -  Signed and dated informed consent obtained from the subject's legal parent/guardian.
             Adequate provisions for assent of children should be provided in accordance with the
             IRB and any local governance.

          -  Age: 5 to less than 7.5 years for females and 5 to less than 8.5 years for males at
             Visit 1.

          -  Subjects must have a diagnosis and history of perennial allergic rhinitis (PAR) as
             follows:

          -  At least a one year clinical history and treatment of PAR (written or verbal
             confirmation from the treating physician) and,

          -  A documented, positive skin test to an appropriate perennial allergen (animal dander,
             house dust mites, cockroaches and/or mold) or documented, historical, in vitro test
             results for a specific IgE (such as RAST, PRIST) within the past 12 months prior to
             Visit 1 will be allowed. A positive skin test during Visit 1 will also be allowed. A
             positive skin test is defined as a wheal 3mm larger than the diluent control for prick
             testing.

        Note: Subjects who meet the above criteria and who may also have seasonal allergic rhinitis
        (SAR) and/or non-allergic rhinitis (NAR) are eligible for randomization.

          -  At Visit 2, the daily rTNSS on any 4 of the last 7 days prior to Visit 2 must be 5.
             Subjects should refrain from using rescue medication during the 7 days prior to Visit
             2.

          -  Pre-pubescence: Tanner Staging equal to 1 for all classifications as assessed by the
             investigator during each of the five baseline study visits (Visit 1 through Visit 5).
             The same investigator should perform this assessment throughout the study for a
             respective subject, if possible, for consistency of assessment. Details are provided
             in the SPM.

          -  Current height measurement via standardized stadiometer is within the 3rd and 97th
             percentile according to the CDC and any local longitudinal standard height charts for
             age and gender as provided in the SPM (Visit 1 through Visit 5).

          -  Body weight and body mass index between the 3rd and 97th percentile according to the
             US CDC standards and any local standards as assessed during each of the five baseline
             study visits (Visit 1 through Visit 5). The US CDC standards are provided in the SPM.

          -  Compliance: Subject's parent/guardian is literate and both subject and parent/guardian
             are deemed capable of complying with all study procedures to include proper study drug
             administration, daily e-diary completion, in-clinic laboratory assessments, and
             in-home 24 hour urine collection during the 76 weeks of study participation (Visit 1
             through Visit 5).

        Exclusion criteria:

          -  A history or evidence of abnormal growth. Any previous or current condition that
             affects growth, including sleep disorders.

          -  Asthma, with the exception of mild intermittent asthma [National Asthma Education and
             Prevention Program, 2007] (Note: Subjects will be allowed to use short-acting inhaled
             beta2 agonists only on an as needed basis.)

          -  A history of nasal or sinus surgery, septal perforation, or severe obstruction in the
             nose (e.g. nasal polyps).

          -  Any other significant concomitant medical condition. 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. (Visit 1 through
             Visit 5)

          -  Any prior or current use of any medication/treatment that might affect growth
             including, but not limited to, methylphenidate hydrochloride, thyroid hormone, growth
             hormone, anabolic steroids, calcitonin, estrogens, progestins, biphosphonates,
             anticonvulsants or phosphate binding antacids. (Visit 1 through Visit 5).

          -  Use of corticosteroids, defined as:

          -  Inhaled, intranasal, or high potency topical (to include dermatological, optic and
             otic) corticosteroids within 6 weeks prior to Visit 1 or during the baseline period
             (Visit 1 through Visit 5).

          -  Systemic corticosteroids (to include oral and injectable) within 12 weeks prior to
             Visit 1 or during the baseline period (Visit 1 through Visit 5).

          -  Use of other allergy medications within an appropriate timeframe relative to Visit 1
             to allow the medication to be eliminated or no longer producing an effect as well as
             during the baseline period (Visit 1 through Visit 5) including, but not limited to:

          -  Intranasal cromolyn - 14 days

          -  Short-acting prescription and OTC antihistamines - 3 days

          -  Long acting (second-generation) antihistamines (other than the loratadine syrup
             supplied by GSK to treat uncontrolled symptoms of PAR) including fexofenadine,
             cetirizine, desloratadine, and astemizole - 10 days

          -  Long-acting antihistamine: astemizole - 12 weeks

          -  Intranasal antihistamines (e.g. azelastine) -2 weeks

          -  Oral or intranasal decongestants - 3 days

          -  Intranasal, oral or inhaled anticholinergics - 3 days

          -  Oral antileukotrienes - 3 days

          -  Subcutaneous omalizumab - 5 months

          -  Immunotherapy initiated or adjusted within 30 days prior to Visit 1 or during the
             baseline period (Visit 1 through Visit 5) noting that no significant changes in the
             dose, concentration or dilution will be allowed during the study.

          -  Use of immunosuppressive medications 8 weeks prior to screening or during the baseline
             period (Visit 1 through Visit 5) of the study.

          -  Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme
             CYP3A4, including ritonavir and ketoconazole. (Visit 1 through Visit 5)

          -  Allergy/Intolerance

          -  Known hypersensitivity to corticosteroids or any excipients in the nasal spray

          -  Known hypersensitivity to the antihistamine or decongestant being provided for
             worsening symptoms of rhinitis during the conduct of the study.

          -  Exposure to varicella (Chickenpox) or measles during the 3 weeks prior to screening or
             during the baseline period (Visit 1 through Visit 5), if non-immune. A diagnosis of
             varicella or measles during the baseline period is exclusionary as well.

          -  Recent exposure to an investigational study drug within 30 days prior toVisit 1.

          -  Affiliation with investigational site.

          -  Findings of a clinically significant, abnormal screening (Visit 1) clinical laboratory
             test.