A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Center Study to Compare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease

Johns Hopkins University0 sites7 target enrollmentNovember 2009

ConditionsPatients With Nasal Polyps

Interventionsfluticasone furoate placebo

Drugsfluticasone furoate

Overview

Phase: Phase 4
Intervention: fluticasone furoate
Conditions: Patients With Nasal Polyps
Sponsor: Johns Hopkins University
Enrollment: 7
Primary Endpoint: To Evaluate the Effect of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray (110 mcg/Day) in Suppressing Nasal Polyp-induced Symptoms Over the Course of 16 Weeks in Patients Presenting to the Clinic With Active Nasal Polypoid Disease.
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Fluticasone furoate is being studied to determine whether treatment with a topical nasal steroid, in patients with existing nasal polyps , can not only improve symptoms but also suppress the recurrence of clinically significant nasal polyp obstruction and prevent surgical intervention.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

July 29, 2010

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johns Hopkins University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female patients 18-70 years of age, in general good health.
•Current evidence of nasal polyps on physical exam. 3) Able to understand the protocol and comply with instructions. 4) Have a negative urine pregnancy test in women of childbearing potential. 5) Women of childbearing potential must be on an acceptable method of birth control or willing to remain abstinent through the duration of the study.

Exclusion Criteria

•Are pregnant and/or breast-feeding.
•History of alcohol or drug abuse in the past year.
•Signs and symptoms suggestive of fulminant bacterial sinusitis (fever \>101 F, persistent severe unilateral facial or tooth pain, facial swelling).
•Allergies to nasal corticosteroids
•.Other chronic significant medical illnesses 6) Maintenance oral prednisone therapy for other chronic medical conditions.

Arms & Interventions

Fluticasone Furoate

nasal steroid

Intervention: fluticasone furoate

Placebo

nasal spray vehicle without drug

Intervention: placebo

Outcomes

Primary Outcomes

To Evaluate the Effect of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray (110 mcg/Day) in Suppressing Nasal Polyp-induced Symptoms Over the Course of 16 Weeks in Patients Presenting to the Clinic With Active Nasal Polypoid Disease.

Time Frame: 18 weeks

Secondary Outcomes

To Evaluate the Efficacy and Safety of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray in Suppressing the Signs of Recurrence of Nasal Polyps Over the Course of 16 Weeks.(18 weeks)