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

NCT ID: NCT00570492

Last Updated: 2017-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-26
• Study Completion Date: 2011-03-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo nasal spray

Group Type: PLACEBO_COMPARATOR

Placebo nasal spray

Intervention Type: DRUG

Placebo nasal spray

Fluticasone furoate nasal spray

Group Type: EXPERIMENTAL

Fluticasone furoate nasal spray

Intervention Type: DRUG

Fluticasone furoate nasal spray 110mg QD

Interventions

Fluticasone furoate nasal spray

Fluticasone furoate nasal spray 110mg QD

Intervention Type: DRUG

Placebo nasal spray

Placebo nasal spray

Intervention Type: DRUG

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Oxford, Alabama, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Riverside, California, United States

GSK Investigational Site

Rolling Hills Estates, California, United States

GSK Investigational Site

Vista, California, United States

GSK Investigational Site

Coral Gables, Florida, United States

GSK Investigational Site

Ocala, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Gainesville, Georgia, United States

GSK Investigational Site

Lawrenceville, Georgia, United States

GSK Investigational Site

Stockbridge, Georgia, United States

GSK Investigational Site

Evansville, Indiana, United States

GSK Investigational Site

Indianapolis, Indiana, United States

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Metairie, Louisiana, United States

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

Ypsilanti, Michigan, United States

GSK Investigational Site

Plymouth, Minnesota, United States

GSK Investigational Site

Rolla, Missouri, United States

GSK Investigational Site

Warrensburg, Missouri, United States

GSK Investigational Site

Bellevue, Nebraska, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Canton, Ohio, United States

GSK Investigational Site

Sylvania, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Medford, Oregon, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

Altoona, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Upland, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Orangeburg, South Carolina, United States

GSK Investigational Site

Spartanburg, South Carolina, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

El Paso, Texas, United States

GSK Investigational Site

El Paso, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Kerrville, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Waco, Texas, United States

GSK Investigational Site

South Burlington, Vermont, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Nueve de Julio, Buenos Aires, Argentina

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Mendoza, , Argentina

GSK Investigational Site

Santa Fe, , Argentina

GSK Investigational Site

Winnipeg, Manitoba, Canada

GSK Investigational Site

Brampton, Ontario, Canada

GSK Investigational Site

Mississauga, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Charlottetown, Prince Edward Island, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Trois-Rivières, Quebec, Canada

GSK Investigational Site

Viña del Mar, Región de Valparaíso, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Laon, , France

GSK Investigational Site

Le Havre, , France

GSK Investigational Site

Montpellier, , France

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Perugia, Umbria, Italy

GSK Investigational Site

Lima, , Peru

Countries

United States; Argentina; Canada; Chile; France; Italy; Peru

References

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.

Reference Type: DERIVED

PMID: 25017530 (View on PubMed)

Study Documents

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

FFR101782

Identifier Type: -

Identifier Source: org_study_id