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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Johns Hopkins University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01013701
First received: November 13, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 13, 2009
November 13, 2009
November 2009
November 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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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 ] [ Designated as safety issue: No ]
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, Doubel-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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Not yet recruiting
30
November 2010
November 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.

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Both
18 Years to 70 Years
Yes
Not Provided
 
NCT01013701
NA_00029405
Yes
Peter S. Creticos, M.D., Johns Hopkins University
Johns Hopkins University
GlaxoSmithKline
Not Provided
Johns Hopkins University
November 2009

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