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Home > Protocol Summaries: Compounds > fluticasone furoate > Protocol Summary for FFU109047

Protocol Summary for FFU109047

Protocol Summary
Protocol Id: FFU109047
Secondary Ids:
Title: A Comparison of Fluticasone Furoate Nasal Spray versus Oral Fexofenadine in the treatment of seasonal allergic rhinitis
Phase: phase 4
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: 00
Has Expanded Access?:
Study Type: Interventional
Oversight Authority:
  • United States: Food and Drug Administration
Collaborators:
Brief Summary: The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine
Detailed Description:
Record Verification Date: July 2010
Status: Completed
Why Study Stopped:
Study Start Date: August 2007
Study Completion Date: November 2007
Study Completion Date Type: Actual
Primary Completion Date: November 2007
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject: None
Masked Caregiver: None
Masked Investigator: None
Masked Assessor: None
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Efficacy Study
Primary Outcomes:
  • The mean change from baseline over the two-week treatment period in the nighttime symptoms score.
Secondary Outcomes:
  • The mean change from baseline over the two-week treatment period in N-rTNSS, D-rTNSS, 24-hour rTNSS, N-rTOSS, D-rTOSS, 24-hour rTOSS, pre-dose iTNSS, pre-dose iTOSS
  • Mean change from baseline over the two-week treatment period in the following:
  • • Nighttime, Daytime, and 24-hour reflective total nasal symptom scores (N-rTNSS, D-rTNSS, and 24-hour rTNSS, respectively)
  • • Nighttime, Daytime, and 24-hour reflective total ocular symptom scores (N-rTOSS, D-rTOSS, and 24-hour rTOSS, respectively)
  • • Pre-dose instantaneous total nasal and ocular symptom scores, (iTNSS and iTOSS, respectively)
  • • Peak inspiratory nasal flow (PNIF)
  • Mean change from baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) results
  • Frequency and type of clinical adverse events (AEs)
Conditions:
  • Rhinitis, Allergic, Seasonal
Keywords:
  • allergic rhinitis
  • ragweed
  • once daily
  • fluticasone furoate
  • fexofenadine
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 12 Year
Maximum Age:
Enrollment: 678
Enrollment Type:
Healthy Volunteers?: none
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