Official Title: “A Randomized, Doubel-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”

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

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2010

Intervention(s) in this Clinical Trial

• Drug: fluticasone furoate
  • nasal steroid spray
• Other: placebo
  • nasal steroid vehicle without drug

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Fluticasone Furoate
  • nasal steroid
• Placebo Comparator: Placebo
  • nasal spray vehicle without drug

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No

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.
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Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Johns Hopkins University

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01013701

Study ID Number: NA_00029405

ClinicalTrials.gov Identifier: NCT01013701

Health Authority: United States: Institutional Review Board