Compare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease

Phase 4TerminatedNCT01013701

Johns Hopkins University7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Patients With Nasal Polyps

Interventions

fluticasone furoateDRUG

nasal steroid spray

placeboOTHER

nasal steroid vehicle without drug

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and female patients 18-70 years of age, in general good health. 2. 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: 1. Are pregnant and/or breast-feeding. 2. History of alcohol or drug abuse in the past year. 3. Signs and symptoms suggestive of fulminant bacterial sinusitis (fever \>101 F, persistent severe unilateral facial or tooth pain, facial swelling). 4. Allergies to nasal corticosteroids 5. .Other chronic significant medical illnesses 6) Maintenance oral prednisone therapy for other chronic medical conditions. \- \-

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.

Time frame: 18 weeks

Data from ClinicalTrials.gov

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