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

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ClinicalTrials.gov Identifier: NCT01013701
Recruitment Status : Terminated (Terminated based on mutual agreement between PI and sponsor (Glaxo Smith Kline))
First Posted : November 16, 2009
Results First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Patients With Nasal Polyps Drug: fluticasone furoate Other: placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2009
Actual Primary Completion Date : July 29, 2010
Actual Study Completion Date : July 29, 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Fluticasone Furoate
nasal steroid
 Drug: fluticasone furoate
nasal steroid spray
Placebo Comparator: Placebo
nasal spray vehicle without drug
 Other: placebo
nasal steroid vehicle without drug


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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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Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01013701    
Other Study ID Numbers: NA_00029405
First Posted: November 16, 2009    Key Record Dates
Results First Posted: September 13, 2017
Last Update Posted: September 13, 2017
Last Verified: August 2017
Keywords provided by Johns Hopkins University:
nasal polyps
nasal steroid
fluticasone furoate
Additional relevant MeSH terms:
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Nasal Polyps
Polyps
Pathological Conditions, Anatomical
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Fluticasone
Xhance
Anti-Inflammatory Agents
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents