- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01013701
Compare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease
August 15, 2017 updated by: Johns Hopkins University
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Fluticasone Furoate
nasal steroid
|
nasal steroid spray
|
Placebo Comparator: Placebo
nasal spray vehicle without drug
|
nasal steroid vehicle without drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2009
Primary Completion (Actual)
July 29, 2010
Study Completion (Actual)
July 29, 2010
Study Registration Dates
First Submitted
November 13, 2009
First Submitted That Met QC Criteria
November 13, 2009
First Posted (Estimate)
November 16, 2009
Study Record Updates
Last Update Posted (Actual)
September 13, 2017
Last Update Submitted That Met QC Criteria
August 15, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Pathological Conditions, Anatomical
- Nose Diseases
- Polyps
- Nasal Polyps
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Fluticasone
- Xhance
Other Study ID Numbers
- NA_00029405
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patients With Nasal Polyps
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University Hospital, LilleRecruitingChronic Rhinosinusitis With Nasal PolypsFrance
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Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingChronic Rhinosinusitis With Nasal PolypsItaly
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Medical University of South CarolinaRecruitingChronic Rhinosinusitis With Nasal PolypsUnited States
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Fondazione Policlinico Universitario Agostino Gemelli...Active, not recruitingChronic Rhinosinusitis With Nasal PolypsItaly
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Centre hospitalier de l'Université de Montréal...RecruitingChronic Rhinosinusitis With Nasal PolypsCanada
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SanofiRegeneron PharmaceuticalsCompletedChronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)Belgium, Mexico, Turkey, Israel, Spain, Sweden, Argentina, Canada, Japan, United States, Australia, Chile, Portugal, Russian Federation
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GB001, Inc, a wholly owned subsidiary of Gossamer...CompletedChronic Rhinosinusitis Without Nasal Polyps (CRSsNP) | Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)United States, Czechia, Ukraine
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Ohio State UniversityActive, not recruitingChronic Rhinosinusitis With Nasal Polyps | Chronic Rhinosinusitis Without Nasal PolypsUnited States
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Beijing Tongren HospitalNot yet recruitingChronic Rhinosinusitis With Nasal Polyps | GlucocorticoidsChina
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The First Affiliated Hospital with Nanjing Medical...Not yet recruitingChronic Rhinosinusitis With Nasal Polyps (CRSwNP)
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