Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.

Launched by GLAXOSMITHKLINE · Dec 10, 2007

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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.