Compare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease
Information source: Johns Hopkins University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patients With Nasal Polyps
Intervention: fluticasone furoate (Drug); placebo (Other)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Johns Hopkins University
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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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Locations and Contacts
Additional Information
Starting date: November 2009
Last updated: November 13, 2009
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