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

Phase 4

Terminated

• Conditions: Patients With Nasal Polyps
• Interventions: Other: placebo; Drug: fluticasone furoate

• Registration Number: NCT01013701
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-13
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Primary Completion: 2010-07-29
• Study Completion: 2010-07-29
• Results First Submitted: 2017-07-17
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-15
• Last Update Submitted: 2017-08-15
• Results First Posted: 2017-09-13
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	nasal spray vehicle without drug
Fluticasone Furoate	fluticasone furoate	nasal steroid

Primary Outcome Measures

Name	Time	Method
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.	18 weeks

Secondary Outcome Measures

Name	Time	Method
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