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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, January 2009
Sponsored by: 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

Drug Information available for: Fluticasone Fluticasone propionate
U.S. FDA Resources
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

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

  Show 161 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

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

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

Study placed in the following topic categories:
Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Perennial
Hypersensitivity, Immediate
Fluticasone
Rhinitis
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents
Nose Diseases
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 13, 2009