Overview

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

Status:
Terminated

Trial end date:
2010-07-29

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Johns Hopkins University

Collaborator:

GlaxoSmithKline

Treatments:

Fluticasone
Xhance

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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