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Home > Protocol Summaries: Compounds > fluticasone furoate > Protocol Summary for FFU108556

Protocol Summary for FFU108556

Protocol Summary
Protocol Id: FFU108556
Secondary Ids:
Title: A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Fluticasone Propionate Aqueous Nasal Spray in Subject with Allergic Rhinitis
Phase: Phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 48647
IND/IDE Serial Number: 0123
Has Expanded Access?:
Study Type: interventional
Oversight Authority:
  • United States: Food and Drug Administration
Collaborators:
Brief Summary: The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.
Detailed Description:
Record Verification Date: September 2009
Status: Completed
Why Study Stopped:
Study Start Date: December 2006
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: Treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject: None
Masked Caregiver: None
Masked Investigator: None
Masked Assessor: None
Study Design (Assignment): Crossover Assignment
Study Classification (Endpoint): None
Primary Outcomes:
  • overall subject preference for nasal spray
Secondary Outcomes:
  • subject preference for individual attributes
Conditions:
  • Rhinitis, Allergic, Perennial
Keywords:
  • preference
  • attributes
  • scent
  • odor
  • taste
  • after taste
  • questionnaire
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: N/A N/A
Enrollment: 125
Enrollment Type:
Healthy Volunteers?: no
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information