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

NCT00570492 | Completed Phase 4 Results

• 1 other identifier: FFR101782
• Study Type: interventional
• Target: 474
• Locations: 7 countries
• Sites: 74

Brief 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.

Conditions

Rhinitis, Allergic, Perennial

Keywords

allergic rhinitis; fluticasone furoate nasal spray; growth

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Growth Velocity of Pre-pubescent Pediatric Participants to the End of the 52-week Double-blind (DB) Treatment Period

  Height was measured (triplicate measurements) in pre-pubescent pediatric participants via stadiometry at each clinic visit during the entire 76-week study period (16-week Baseline Period, 52-week DB Treatment Period and 8-week Follow-up Period). Growth velocity was calculated by fitting a regression line to all height measurements recorded for the participant during the period and was determined by the slope of the fitted regression line. Change from Baseline was calculated as the value over the 52-week Treatment Period minus the value over the 16-week Baseline Period.

  Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)

Secondary Outcomes (16)

• Mean 24-hour Urinary Free Cortisol Excretion

  Randomization/end of 16-week Baseline Period (Week 0), End of 52-week DB Treatment Period (Week 52), and end of 8-week Follow-up Period (Week 60)

• Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results

  Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)

• Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)

  Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

• Mean Values for the Laboratory Parameters if Albumin and Total Protein

  Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

• Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine

  Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

Study Arms (2)

Placebo nasal spray

PLACEBO COMPARATOR

Drug: Placebo nasal spray

Fluticasone furoate nasal spray

EXPERIMENTAL

Drug: Fluticasone furoate nasal spray

Interventions

Fluticasone furoate nasal spray DRUG

Fluticasone furoate nasal spray 110mg QD

Fluticasone furoate nasal spray

Placebo nasal spray DRUG

Placebo nasal spray

Placebo nasal spray

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (74)

GSK Investigational Site

Oxford, Alabama, 36203, United States

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GSK Investigational Site

Little Rock, Arkansas, 72205, United States

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GSK Investigational Site

Huntington Beach, California, 92647, United States

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GSK Investigational Site

Long Beach, California, 90806, United States

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GSK Investigational Site

Long Beach, California, 90808, United States

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GSK Investigational Site

Riverside, California, 92506, United States

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GSK Investigational Site

Rolling Hills Estates, California, 90274, United States

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GSK Investigational Site

Vista, California, 92083, United States

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GSK Investigational Site

Coral Gables, Florida, 33134, United States

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GSK Investigational Site

Ocala, Florida, 34471, United States

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GSK Investigational Site

Tampa, Florida, 33613, United States

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GSK Investigational Site

Gainesville, Georgia, 30501, United States

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GSK Investigational Site

Lawrenceville, Georgia, 30045, United States

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GSK Investigational Site

Stockbridge, Georgia, 30281, United States

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GSK Investigational Site

Evansville, Indiana, 47713, United States

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GSK Investigational Site

Indianapolis, Indiana, 46208, United States

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GSK Investigational Site

Lenexa, Kansas, 66215, United States

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GSK Investigational Site

Metairie, Louisiana, 70006, United States

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GSK Investigational Site

Baltimore, Maryland, 21236, United States

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GSK Investigational Site

Ypsilanti, Michigan, 48197, United States

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GSK Investigational Site

Plymouth, Minnesota, 55441, United States

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GSK Investigational Site

Rolla, Missouri, 65401, United States

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GSK Investigational Site

Warrensburg, Missouri, 64093, United States

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GSK Investigational Site

Bellevue, Nebraska, 68123-4303, United States

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GSK Investigational Site

Omaha, Nebraska, 68131, United States

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GSK Investigational Site

Canton, Ohio, 44718, United States

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GSK Investigational Site

Sylvania, Ohio, 43560, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73120, United States

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GSK Investigational Site

Medford, Oregon, 97504, United States

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GSK Investigational Site

Portland, Oregon, 97213, United States

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GSK Investigational Site

Altoona, Pennsylvania, 16801, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15212, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15241, United States

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GSK Investigational Site

Upland, Pennsylvania, 19013, United States

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GSK Investigational Site

Charleston, South Carolina, 29414, United States

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GSK Investigational Site

Orangeburg, South Carolina, 29118, United States

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GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

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GSK Investigational Site

Dallas, Texas, 75230, United States

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GSK Investigational Site

Dallas, Texas, 75246, United States

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GSK Investigational Site

El Paso, Texas, 79903, United States

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GSK Investigational Site

El Paso, Texas, 79925, United States

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GSK Investigational Site

Houston, Texas, 77054, United States

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GSK Investigational Site

Kerrville, Texas, 78028, United States

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GSK Investigational Site

San Antonio, Texas, 78205, United States

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GSK Investigational Site

San Antonio, Texas, 78229, United States

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GSK Investigational Site

Waco, Texas, 76712, United States

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GSK Investigational Site

South Burlington, Vermont, 05403, United States

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GSK Investigational Site

Richmond, Virginia, 23219, United States

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GSK Investigational Site

Richmond, Virginia, 23229, United States

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GSK Investigational Site

Nueve de Julio, Buenos Aires, B6500BWQ, Argentina

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GSK Investigational Site

Rosario, Santa Fe Province, 2000, Argentina

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GSK Investigational Site

Rosario, Santa Fe Province, S2000DBS, Argentina

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GSK Investigational Site

Buenos Aires, 1425, Argentina

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GSK Investigational Site

Buenos Aires, C1121ABE, Argentina

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GSK Investigational Site

Buenos Aires, C1425BEN, Argentina

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GSK Investigational Site

Mendoza, M5500CCG, Argentina

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GSK Investigational Site

Santa Fe, 3000, Argentina

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GSK Investigational Site

Winnipeg, Manitoba, R2M 5L9, Canada

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GSK Investigational Site

Brampton, Ontario, L6T 3T1, Canada

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GSK Investigational Site

Mississauga, Ontario, L5A 3V4, Canada

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GSK Investigational Site

Toronto, Ontario, M4V 1R2, Canada

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GSK Investigational Site

Charlottetown, Prince Edward Island, C1A 8T5, Canada

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GSK Investigational Site

Québec, Quebec, G1V 4M6, Canada

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GSK Investigational Site

Trois-Rivières, Quebec, G8T 7A1, Canada

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GSK Investigational Site

Viña del Mar, Región de Valparaíso, Chile

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GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

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GSK Investigational Site

Laon, 02000, France

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GSK Investigational Site

Le Havre, 76083, France

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GSK Investigational Site

Montpellier, 34295, France

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GSK Investigational Site

Milan, Lombardy, 20122, Italy

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GSK Investigational Site

Milan, Lombardy, 20129, Italy

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GSK Investigational Site

Perugia, Umbria, 06156, Italy

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GSK Investigational Site

Lima, Lima 27, Peru

Location

Related Publications (1)

• Lee LA, Sterling R, Maspero J, Clements D, Ellsworth A, Pedersen S. Growth velocity reduced with once-daily fluticasone furoate nasal spray in prepubescent children with perennial allergic rhinitis. J Allergy Clin Immunol Pract. 2014 Jul-Aug;2(4):421-7. doi: 10.1016/j.jaip.2014.04.008. Epub 2014 May 21.

  PMID: 25017530 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 11, 2007
• Study Start: November 26, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 17, 2011
• Last Updated: September 15, 2017
• Results First Posted: February 7, 2012

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

IT (3); US (50); CL (2); PE (1); AR (8); FR (3); CA (7)