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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
  Purpose

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 Intervention Phase
Patients With Nasal Polyps
 Drug: fluticasone furoate
Other: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

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. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

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. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Peter S. Creticos, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01013701     History of Changes
Other Study ID Numbers: NA_00029405
Study First Received: November 13, 2009
Last Updated: November 13, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
nasal polyps
nasal steroid
fluticasone furoate

Additional relevant MeSH terms:
Nasal Polyps
Polyps
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Fluticasone
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013