Back to resultsCompare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease
Primary Purpose
Patients With Nasal Polyps
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
fluticasone furoate
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Patients With Nasal Polyps focused on measuring nasal polyps, nasal steroid, fluticasone furoate
Eligibility Criteria
Inclusion Criteria:
- Male and female patients 18-70 years of age, in general good health.
- 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:
- Are pregnant and/or breast-feeding.
- History of alcohol or drug abuse in the past year.
- Signs and symptoms suggestive of fulminant bacterial sinusitis (fever >101 F, persistent severe unilateral facial or tooth pain, facial swelling).
- Allergies to nasal corticosteroids
.Other chronic significant medical illnesses 6) Maintenance oral prednisone therapy for other chronic medical conditions.
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Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Fluticasone Furoate
Placebo
Arm Description
nasal steroid
nasal spray vehicle without drug
Outcomes
Primary Outcome Measures
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 Measures
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.
Full Information
NCT ID
NCT01013701
First Posted
November 13, 2009
Last Updated
August 15, 2017
Sponsor
Johns Hopkins University
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT01013701
Brief Title
Compare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease
Official Title
A Randomized, Double-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 Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Terminated based on mutual agreement between PI and sponsor (Glaxo Smith Kline)
Study Start Date
November 2009 (Actual)
Primary Completion Date
July 29, 2010 (Actual)
Study Completion Date
July 29, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Nasal Polyps
Keywords
nasal polyps, nasal steroid, fluticasone furoate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluticasone Furoate
Arm Type
Active Comparator
Arm Description
nasal steroid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
nasal spray vehicle without drug
Intervention Type
Drug
Intervention Name(s)
fluticasone furoate
Intervention Description
nasal steroid spray
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
nasal steroid vehicle without drug
Primary Outcome Measure Information:
Title
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.
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female patients 18-70 years of age, in general good health.
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:
Are pregnant and/or breast-feeding.
History of alcohol or drug abuse in the past year.
Signs and symptoms suggestive of fulminant bacterial sinusitis (fever >101 F, persistent severe unilateral facial or tooth pain, facial swelling).
Allergies to nasal corticosteroids
.Other chronic significant medical illnesses 6) Maintenance oral prednisone therapy for other chronic medical conditions.
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-
12. IPD Sharing Statement
Learn more about this trial
Compare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease
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