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

NCT ID: NCT01013701

Last Updated: 2017-09-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-07-29

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.

Conditions

Patients With Nasal Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Fluticasone Furoate

nasal steroid

Group Type: ACTIVE_COMPARATOR

fluticasone furoate

Intervention Type: DRUG

nasal steroid spray

Placebo

nasal spray vehicle without drug

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

nasal steroid vehicle without drug

Interventions

fluticasone furoate

nasal steroid spray

Intervention Type: DRUG

placebo

nasal steroid vehicle without drug

Intervention Type: OTHER

Eligibility 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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NA_00029405

Identifier Type: -

Identifier Source: org_study_id