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

This study has been terminated.
(Terminated based on mutual agreement between PI and sponsor (Glaxo Smith Kline))
Sponsor:
ClinicalTrials.gov Identifier:
NCT01013701
First Posted: November 16, 2009
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Johns Hopkins University
November 13, 2009
November 16, 2009
July 17, 2017
September 13, 2017
September 13, 2017
November 2009
July 29, 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01013701 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Compare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Patients With Nasal Polyps
  • Drug: fluticasone furoate
    nasal steroid spray
  • Other: placebo
    nasal steroid vehicle without drug
  • Active Comparator: Fluticasone Furoate
    nasal steroid
    Intervention: Drug: fluticasone furoate
  • Placebo Comparator: Placebo
    nasal spray vehicle without drug
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
July 29, 2010
July 29, 2010   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01013701
NA_00029405
Yes
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
GlaxoSmithKline
Not Provided
Johns Hopkins University
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP