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Clinical Trials
NCT00502775

Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

Last Updated: 2016-12-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

680 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-11-30

Brief Summary

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

Detailed Description

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Conditions

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Rhinitis, Allergic, Seasonal

Keywords

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ragweed once daily fexofenadine fluticasone furoate allergic rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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fluticasone furoate, fexofenadine

Intervention Type DRUG

Other Intervention Names

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fluticasone furoate fexofenadine

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

fluticasone furoate, fexofenadine

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

GlaxoSmithKline

Responsible Party

Principal Investigators

GSK Clinical Trials

Locations

GSK Investigational Site

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Countries

Study Documents

Document Type: Clinical Study Report

Document Type: Dataset Specification

Document Type: Statistical Analysis Plan

Document Type: Annotated Case Report Form

Document Type: Study Protocol

Document Type: Individual Participant Data Set

Document Type: Informed Consent Form

Related Links

Other Identifiers

FFU109047