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

Condition(s) targeted: Perennial Allergic Rhinitis

Intervention: fluticasone furoate nasal spray (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Effects of a One-Year Course of Fluticasone Furoate Nasal Spray 110mcg QD on Growth in Pre-Pubescent, Pediatric Subjects With Perennial Allergic Rhinitis

Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study

Primary outcome: The primary endpoint is the mean difference in growth velocities between subjects treated with FFNS 110mcg QD, the highest dose approved for pediatric use in the US, and placebo nasal spray as determined by stadiometry.

Secondary outcome:

Secondary objectives of the study include the evaluation of other safety measures including adverse events, routine chemistry, hematology and urinalysis, 24-hour urinary free cortisol excretion, and nasal examinations.

The frequency and type of clinical adverse events (AEs) experienced during treatment

Results of clinical laboratory tests (chemistry, hematology, urinalysis)

Results of 24-hour urinary cortisol excretion assessments

Results of nasal examinations

Minimum age: 5 Years. Maximum age: 8 Years. Gender(s): Both.

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.

US GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Investigational Site, Ciudad Autónoma de Buenos Aires C1121ABE, Argentina; Recruiting

GSK Investigational Site, Buenos Aires C1425BEN, Argentina; Recruiting

GSK Investigational Site, Buenos Aires 1425, Argentina; Recruiting

GSK Investigational Site, Mendoza M5500CCG, Argentina; Recruiting

GSK Investigational Site, Santa Fe 3000, Argentina; Recruiting

GSK Investigational Site, Montpellier 34295, France; Recruiting

GSK Investigational Site, Laon 02000, France; Recruiting

GSK Investigational Site, Le Havre 76083, France; Recruiting

GSK Investigational Site, Lima Lima 27, Peru; Active, not recruiting

GSK Investigational Site, Oxford, Alabama 36203, United States; Active, not recruiting

GSK Investigational Site, Little Rock, Arkansas 72205, United States; Recruiting

GSK Investigational Site, 9 de Julio, Buenos Aires B6500BWQ, Argentina; Recruiting

GSK Investigational Site, Long Beach, California 90806, United States; Recruiting

GSK Investigational Site, Long Beach, California 90808, United States; Recruiting

GSK Investigational Site, Riverside, California 92506, United States; Recruiting

GSK Investigational Site, Huntington Beach, California 92647, United States; Recruiting

GSK Investigational Site, Vista, California 92083, United States; Recruiting

GSK Investigational Site, Rolling Hills Estates, California 90274, United States; Recruiting

GSK Investigational Site, Coral Gables, Florida 33134, United States; Active, not recruiting

GSK Investigational Site, Tampa, Florida 33613, United States; Active, not recruiting

GSK Investigational Site, Ocala, Florida 34471, United States; Completed

GSK Investigational Site, Stockbridge, Georgia 30281, United States; Completed

GSK Investigational Site, Gainesville, Georgia 30501, United States; Active, not recruiting

GSK Investigational Site, Lawrenceville, Georgia 30045, United States; Active, not recruiting

GSK Investigational Site, Indianapolis, Indiana 46208, United States; Recruiting

GSK Investigational Site, Evansville, Indiana 47713, United States; Recruiting

GSK Investigational Site, Lenexa, Kansas 66215, United States; Recruiting

GSK Investigational Site, Milano, Lombardia 20129, Italy; Not yet recruiting

GSK Investigational Site, Milano, Lombardia 20122, Italy; Recruiting

GSK Investigational Site, Metairie, Louisiana 70006, United States; Completed

GSK Investigational Site, Winnipeg, Manitoba R2M 5L9, Canada; Completed

GSK Investigational Site, Baltimore, Maryland 21236, United States; Active, not recruiting

GSK Investigational Site, Ypsilanti, Michigan 48197, United States; Completed

GSK Investigational Site, Rolla, Missouri 65401, United States; Recruiting

GSK Investigational Site, Warrensburg, Missouri 64093, United States; Recruiting

GSK Investigational Site, Papillion, Nebraska 68046, United States; Recruiting

GSK Investigational Site, Omaha, Nebraska 68131, United States; Recruiting

GSK Investigational Site, Canton, Ohio 44718, United States; Active, not recruiting

GSK Investigational Site, Sylvania, Ohio 43560, United States; Recruiting

GSK Investigational Site, Oklahoma City, Oklahoma 73112, United States; Recruiting

GSK Investigational Site, Oklahoma City, Oklahoma 73120, United States; Recruiting

GSK Investigational Site, Mississauga, Ontario L5A 3V4, Canada; Completed

GSK Investigational Site, Brampton, Ontario L6T 3T1, Canada; Recruiting

GSK Investigational Site, Toronto, Ontario M4V 1R2, Canada; Completed

GSK Investigational Site, Medford, Oregon 97504, United States; Recruiting

GSK Investigational Site, Portland, Oregon 97213, United States; Recruiting

GSK Investigational Site, Pittsburgh, Pennsylvania 15212, United States; Completed

GSK Investigational Site, Pittsburgh, Pennsylvania 15241, United States; Active, not recruiting

GSK Investigational Site, Altoona, Pennsylvania 16801, United States; Completed

GSK Investigational Site, Upland, Pennsylvania 19013, United States; Active, not recruiting

GSK Investigational Site, Charlottetown, Prince Edward Island C1A 8T5, Canada; Completed

GSK Investigational Site, Trois Rivières, Quebec G8T 7A1, Canada; Completed

GSK Investigational Site, Quebec City, Quebec G1V 4M6, Canada; Recruiting

GSK Investigational Site, Santiago, Región Metro De Santiago, Chile; Recruiting

GSK Investigational Site, Rosario, Santa Fe S2000DBS, Argentina; Recruiting

GSK Investigational Site, Rosario, Santa Fe 2000, Argentina; Recruiting

GSK Investigational Site, Charleston, South Carolina 29414, United States; Recruiting

GSK Investigational Site, Orangeburg, South Carolina 29118, United States; Active, not recruiting

GSK Investigational Site, Spartanburg, South Carolina 29303, United States; Active, not recruiting

GSK Investigational Site, El Paso, Texas 79925, United States; Recruiting

GSK Investigational Site, San Antonio, Texas 78205, United States; Recruiting

GSK Investigational Site, Houston, Texas 77054, United States; Recruiting

GSK Investigational Site, San Antonio, Texas 78229, United States; Recruiting

GSK Investigational Site, Kerrville, Texas 78028, United States; Recruiting

GSK Investigational Site, Waco, Texas 76712, United States; Recruiting

GSK Investigational Site, Dallas, Texas 75246, United States; Completed

GSK Investigational Site, El Paso, Texas 79903, United States; Recruiting

GSK Investigational Site, Dallas, Texas 75230, United States; Active, not recruiting

GSK Investigational Site, Perugia, Umbria 06156, Italy; Recruiting

GSK Investigational Site, Viña del Mar, Valparaíso, Chile; Recruiting

GSK Investigational Site, South Burlington, Vermont 05403, United States; Recruiting

GSK Investigational Site, Richmond, Virginia 23229, United States; Active, not recruiting

GSK Investigational Site, Richmond, Virginia 23219, United States; Active, not recruiting

Starting date: November 2007
Last updated: October 8, 2009