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

Patients With Nasal Polyps Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01013701
• Other study ID #: NA_00029405
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 13, 2009
• Last updated: November 13, 2009
• Start date: November 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasal Polyps
• Patients With Nasal Polyps

Intervention

Drug:
• fluticasone furoate
nasal steroid spray

Other:
• placebo
nasal steroid vehicle without drug

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No