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Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rhinitis, Allergic, Seasonal

Intervention: fluticasone furoate, fexofenadine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

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

Summary

The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine

Clinical Details

Official title: A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Mean Change From Baseline in the Nighttime Symptom Score (NSS)

Secondary outcome:

Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)

Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)

Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)

Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)

Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)

Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)

Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)

Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)

Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)

Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)

Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- Informed consent

- Otherwise healthy outpatient with mountain cedar allergy

- Male or eligible female Females of childbearing potential must commit to the

consistent and correct use of an acceptable method of birth control

- Age 12 years or older at Visit 2

- Diagnosis of seasonal allergic rhinitis (SAR) to mountain cedar

- Adequate exposure to mountain cedar pollen

- Ability to comply with study procedures

- Literate

Exclusion criteria:

- Significant concomitant medical conditions

- Use of intranasal corticosteroids within four weeks prior to Visit 1; use of

inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1.

- Use of other allergy medications within specific timeframes relative to Visit 1

- Use of other medications that may affect allergic rhinitis or its symptoms

- Use of immunosuppressive medications eight weeks prior to screening and during the

study

- Immunotherapy patients who are not stable on current dose

- Use of any medications that significantly alters the pharmacokinetics of fluticasone

furoate or fexofenadine

- Allergy/Intolerance to corticosteroids, antihistamines, or any excipients in the two

products

- Use of contact lenses

- Recent clinical trial/experimental medication experience within 30 days of Visit 1

- Subject previously failed the 21-day screen period or failed to complete the

treatment period

- Positive or inconclusive pregnancy test or female who is breastfeeding

- Employee or relative affiliation with investigational site

- Current tobacco use

- Active chickenpox or measles or exposure in the last 3 weeks

Locations and Contacts

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

GSK Investigational Site, Albany, Georgia 31707, United States

GSK Investigational Site, Columbus, Georgia 31904, United States

GSK Investigational Site, Lawrenceville, Georgia 30045, United States

GSK Investigational Site, Chicago, Illinois 60637, United States

GSK Investigational Site, Normal, Illinois 61761, United States

GSK Investigational Site, Evansville, Indiana 47713, United States

GSK Investigational Site, Indianapolis, Indiana 46208, United States

GSK Investigational Site, Lafayette, Indiana 47904, United States

GSK Investigational Site, South Bend, Indiana 46617, United States

GSK Investigational Site, Iowa City, Iowa 52242, United States

GSK Investigational Site, Louisville, Kentucky 40215, United States

GSK Investigational Site, Owensboro, Kentucky 42301, United States

GSK Investigational Site, Metairie, Louisiana 70006, United States

GSK Investigational Site, Sunset, Louisiana 70584, United States

GSK Investigational Site, Novi, Michigan 48375, United States

GSK Investigational Site, Ypsilanti, Michigan 48197, United States

GSK Investigational Site, Minneapolis, Minnesota 55402, United States

GSK Investigational Site, Plymouth, Minnesota 55441, United States

GSK Investigational Site, Jackson, Mississippi 39202, United States

GSK Investigational Site, Columbia, Missouri 65203, United States

GSK Investigational Site, Rolla, Missouri 65401, United States

GSK Investigational Site, St. Louis, Missouri 63110, United States

GSK Investigational Site, St. Louis, Missouri 63141, United States

GSK Investigational Site, Warrensburg, Missouri 64093, United States

GSK Investigational Site, Lincoln, Nebraska 68505, United States

GSK Investigational Site, Omaha, Nebraska 68130, United States

GSK Investigational Site, Omaha, Nebraska 68124, United States

GSK Investigational Site, Papillion, Nebraska 68046, United States

GSK Investigational Site, Canton, Ohio 44718, United States

GSK Investigational Site, Cincinnati, Ohio 45231, United States

GSK Investigational Site, Sylvania, Ohio 43560, United States

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

GSK Investigational Site, Pittsburgh, Pennsylvania 15241, United States

GSK Investigational Site, Charleston, South Carolina 29407, United States

GSK Investigational Site, Orangeburg, South Carolina 29118, United States

GSK Investigational Site, Spartanburg, South Carolina 29303, United States

GSK Investigational Site, Knoxville, Tennessee 37909, United States

GSK Investigational Site, Waco, Texas 76712, United States

GSK Investigational Site, Greenfield, Wisconsin 53228, United States

GSK Investigational Site, Milwaukee, Wisconsin 53209, United States

GSK Investigational Site, West Allis, Wisconsin 53227, United States

Additional Information

Starting date: August 2007
Last updated: June 15, 2015

Page last updated: August 23, 2015

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