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Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.
This study is currently recruiting participants.
Verified by GlaxoSmithKline, October 2009
First Received: December 6, 2007   Last Updated: October 8, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00570492
  Purpose

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.


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: fluticasone furoate nasal spray
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Measures:
  • 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

Estimated Enrollment: 450
Study Start Date: November 2007
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570492

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site Active, not recruiting
Oxford, Alabama, United States, 36203
United States, Arkansas
GSK Investigational Site Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site Recruiting
Long Beach, California, United States, 90806
GSK Investigational Site Recruiting
Long Beach, California, United States, 90808
GSK Investigational Site Recruiting
Riverside, California, United States, 92506
GSK Investigational Site Recruiting
Huntington Beach, California, United States, 92647
GSK Investigational Site Recruiting
Vista, California, United States, 92083
GSK Investigational Site Recruiting
Rolling Hills Estates, California, United States, 90274
United States, Florida
GSK Investigational Site Active, not recruiting
Coral Gables, Florida, United States, 33134
GSK Investigational Site Active, not recruiting
Tampa, Florida, United States, 33613
GSK Investigational Site Completed
Ocala, Florida, United States, 34471
United States, Georgia
GSK Investigational Site Completed
Stockbridge, Georgia, United States, 30281
GSK Investigational Site Active, not recruiting
Gainesville, Georgia, United States, 30501
GSK Investigational Site Active, not recruiting
Lawrenceville, Georgia, United States, 30045
United States, Indiana
GSK Investigational Site Recruiting
Indianapolis, Indiana, United States, 46208
GSK Investigational Site Recruiting
Evansville, Indiana, United States, 47713
United States, Kansas
GSK Investigational Site Recruiting
Lenexa, Kansas, United States, 66215
United States, Louisiana
GSK Investigational Site Completed
Metairie, Louisiana, United States, 70006
United States, Maryland
GSK Investigational Site Active, not recruiting
Baltimore, Maryland, United States, 21236
United States, Michigan
GSK Investigational Site Completed
Ypsilanti, Michigan, United States, 48197
United States, Missouri
GSK Investigational Site Recruiting
Rolla, Missouri, United States, 65401
GSK Investigational Site Recruiting
Warrensburg, Missouri, United States, 64093
United States, Nebraska
GSK Investigational Site Recruiting
Papillion, Nebraska, United States, 68046
GSK Investigational Site Recruiting
Omaha, Nebraska, United States, 68131
United States, Ohio
GSK Investigational Site Active, not recruiting
Canton, Ohio, United States, 44718
GSK Investigational Site Recruiting
Sylvania, Ohio, United States, 43560
United States, Oklahoma
GSK Investigational Site Recruiting
Oklahoma City, Oklahoma, United States, 73112
GSK Investigational Site Recruiting
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
GSK Investigational Site Recruiting
Medford, Oregon, United States, 97504
GSK Investigational Site Recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
GSK Investigational Site Completed
Pittsburgh, Pennsylvania, United States, 15212
GSK Investigational Site Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15241
GSK Investigational Site Completed
Altoona, Pennsylvania, United States, 16801
GSK Investigational Site Active, not recruiting
Upland, Pennsylvania, United States, 19013
United States, South Carolina
GSK Investigational Site Recruiting
Charleston, South Carolina, United States, 29414
GSK Investigational Site Active, not recruiting
Orangeburg, South Carolina, United States, 29118
GSK Investigational Site Active, not recruiting
Spartanburg, South Carolina, United States, 29303
United States, Texas
GSK Investigational Site Recruiting
El Paso, Texas, United States, 79925
GSK Investigational Site Recruiting
San Antonio, Texas, United States, 78205
GSK Investigational Site Recruiting
Houston, Texas, United States, 77054
GSK Investigational Site Recruiting
San Antonio, Texas, United States, 78229
GSK Investigational Site Active, not recruiting
Dallas, Texas, United States, 75230
GSK Investigational Site Recruiting
Waco, Texas, United States, 76712
GSK Investigational Site Completed
Dallas, Texas, United States, 75246
GSK Investigational Site Recruiting
El Paso, Texas, United States, 79903
GSK Investigational Site Recruiting
Kerrville, Texas, United States, 78028
United States, Vermont
GSK Investigational Site Recruiting
South Burlington, Vermont, United States, 05403
United States, Virginia
GSK Investigational Site Active, not recruiting
Richmond, Virginia, United States, 23229
GSK Investigational Site Active, not recruiting
Richmond, Virginia, United States, 23219
Argentina
GSK Investigational Site Recruiting
Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
GSK Investigational Site Recruiting
Buenos Aires, Argentina, C1425BEN
GSK Investigational Site Recruiting
Buenos Aires, Argentina, 1425
GSK Investigational Site Recruiting
Mendoza, Argentina, M5500CCG
GSK Investigational Site Recruiting
Santa Fe, Argentina, 3000
Argentina, Buenos Aires
GSK Investigational Site Recruiting
9 de Julio, Buenos Aires, Argentina, B6500BWQ
Argentina, Santa Fe
GSK Investigational Site Recruiting
Rosario, Santa Fe, Argentina, S2000DBS
GSK Investigational Site Recruiting
Rosario, Santa Fe, Argentina, 2000
Canada, Manitoba
GSK Investigational Site Completed
Winnipeg, Manitoba, Canada, R2M 5L9
Canada, Ontario
GSK Investigational Site Completed
Mississauga, Ontario, Canada, L5A 3V4
GSK Investigational Site Recruiting
Brampton, Ontario, Canada, L6T 3T1
GSK Investigational Site Completed
Toronto, Ontario, Canada, M4V 1R2
Canada, Prince Edward Island
GSK Investigational Site Completed
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
GSK Investigational Site Completed
Trois Rivières, Quebec, Canada, G8T 7A1
GSK Investigational Site Recruiting
Quebec City, Quebec, Canada, G1V 4M6
Chile, Región Metro De Santiago
GSK Investigational Site Recruiting
Santiago, Región Metro De Santiago, Chile
Chile, Valparaíso
GSK Investigational Site Recruiting
Viña del Mar, Valparaíso, Chile
France
GSK Investigational Site Recruiting
Montpellier, France, 34295
GSK Investigational Site Recruiting
Laon, France, 02000
GSK Investigational Site Recruiting
Le Havre, France, 76083
Italy, Lombardia
GSK Investigational Site Not yet recruiting
Milano, Lombardia, Italy, 20129
GSK Investigational Site Recruiting
Milano, Lombardia, Italy, 20122
Italy, Umbria
GSK Investigational Site Recruiting
Perugia, Umbria, Italy, 06156
Peru
GSK Investigational Site Active, not recruiting
Lima, Peru, Lima 27
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: FFR101782
Study First Received: December 6, 2007
Last Updated: October 8, 2009
ClinicalTrials.gov Identifier: NCT00570492     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
fluticasone furoate nasal spray
allergic rhinitis
growth

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Otorhinolaryngologic Diseases
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Rhinitis
Anti-Allergic Agents
Pharmacologic Actions
Nose Diseases
Hypersensitivity
Rhinitis, Allergic, Perennial
Respiratory Tract Diseases
Respiratory Tract Infections
Autonomic Agents
Therapeutic Uses
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 25, 2009