Study In Adults And Adolescents With Seasonal Allergic Rhinitis

Seasonal Allergic Rhinitis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 14 Days in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115622
• Other study ID #: FFR30003
• Status: Completed
• Phase: Phase 3
• First received: June 23, 2005
• Last updated: August 30, 2016
• Start date: December 2004
• Est. completion date: January 2005

Study information

• Verified date: August 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion criteria:

• Informed consent.

• Outpatient.

• Females must use appropriate contraception.

• Diagnosis of seasonal allergic rhinitis.

• Adequate exposure to allergen.

• Able to comply with study procedures.

• Literate.

Exclusion criteria:

• Significant concomitant medical condition.

• Use of corticosteroids, allergy medications, or tobacco.

• Clinically significant abnormal ECG.

• Laboratory abnormality.

• Positive pregnancy test.

• Allergy to any component of the investigational product.

Study Design

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

Related Conditions & MeSH terms

• Hayfever
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• fluticasone furoate

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	New Braunfels	Texas
United States	GSK Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (4)

Hampel FC Jr, Jacobs R, Martin B. Toler T, Ellsworth A, Philpot E. Once-daily fluticasone furoate* nasal spray (FF) provides 24-hour symptom relief in subjects with seasonal allergic rhinitis (SAR) caused by mountain cedar pollen. *USAN approved name. J

Jacobs R, Martin B, Hampel F, Toler W, Ellsworth A, Philpot E. Effectiveness of fluticasone furoate 110 microg once daily in the treatment of nasal and ocular symptoms of seasonal allergic rhinitis in adults and adolescents sensitized to mountain cedar pollen. Curr Med Res Opin. 2009 Jun;25(6):1393-401. doi: 10.1185/03007990902890512. — View Citation

Ratner P, Andrews C, van Bavel J, Toler T, Ellsworth A, Philpot E. Once-daily fluticasone furoate* nasal spray (FF) effectively treats ocular symptoms of seasonal allergic rhinitis (SAR) caused by mountain cedar pollen. *USAN approved name. J Allergy Cli

van Bavel J, Toler T, Ellsworth A, Stanford R, Philpot E. Once-daily fluticasone furoate* nasal spray (FFNS) improves quality of life (QoL) in subjects with seasonal allergic rhinitis (SAR) during the mountain cedar pollen season. *USAN approved name. J

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores.			No
Primary	Mean change from baseline over the entire treatment period in the daily, reflective, total ocular symptom score.			No
Secondary	Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous, total nasal symptom score.			No

External Links

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