Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-20

Study Completion Date

2007-02-28

Brief Summary

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

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Detailed Description

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Conditions

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Rhinitis, Allergic, Seasonal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Fluticasone furoate and fexofenadine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent.
* Outpatient.
* Females of child-bearing potential must use appropriate contraception.
* Diagnosis of seasonal allergic rhinitis to mountain cedar.
* Adequate exposure to allergen.
* Able to comply with study procedures.
* Literate.

Exclusion Criteria

* Significant concomitant medical condition.
* Use of corticosteroids, allergy medications, or other medication that affect allergic rhinitis
* Positive pregnancy test.
* Allergy to any component of the investigational product.
* Tobacco use
* Contact lens use
* Has chickenpox or measles or recent exposure
* Other clinical trial drug exposure in last 30 days
* Affiliation with clinic site

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Austin, Texas, United States

Site Status

GSK Investigational Site

Austin, Texas, United States

Site Status

GSK Investigational Site

Kerrville, Texas, United States

Site Status

GSK Investigational Site

New Braunfels, Texas, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Andrews C, Martin B, Jacobs R, Toler T, Prillaman B, Philpot E. Efficacy of fluticasone furoate nasal spray versus oral fexofenadine on nighttime sleep disturbance caused by seasonal allergic rhinitis (SAR) nasal symptoms. Ann Allergy Asthma Immunol 2008; 100(1) (Supplement 1):A6 (abstract)

Reference Type BACKGROUND

Andrews CP, Martin BG, Jacobs RL, Diaz J, Toler WT, Prillaman BA, Dalal AA, Philpot EE. Once-daily fluticasone furoate nasal spray showed greater improvement in nocturnal quality of life in subjects with seasonal allergic rhinitis compared with oral fexofenadine. J Allergy Clin Immunol 2008;121(2) (Supplement 1): S53 (abstract)

Reference Type BACKGROUND

Andrews CP, Martin BG, Jacobs RL, Mohar DE, Diaz JD, Amar NJ, Kaiser HB, Vandewalker ML, Bernstein J, Toler WT, Prillaman BA, Dalal AA, Lee LA, Philpot EE. Fluticasone furoate nasal spray is more effective than fexofenadine for nighttime symptoms of seasonal allergy. Allergy Asthma Proc. 2009 Mar-Apr;30(2):128-38. doi: 10.2500/aap.2009.30.3204.

Reference Type BACKGROUND

PMID: 19463203 (View on PubMed)

Martin BG, Andrews CP, Jacobs R, Mohar D, Toler WT, Prillaman BA, Philpot EE. Once-daily fluticasone furoate nasal spray showed greater improvements in relieving nighttime nasal symptoms and increasing peak nasal inspiratory flow versus oral fexofenadine in subjects with seasonal allergic rhinitis (SAR) J Allergy Clin Immunol 2008;121(2) (Supplement 1): S54-S55 (abstract)

Reference Type BACKGROUND

Study Documents

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