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Protocol Summary for FFR30007

Protocol Summary
Protocol Id: FFR30007
Secondary Ids:
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Vasomotor 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: 48,647
IND/IDE Serial Number: 0048
Has Expanded Access?: no
Study Type: Interventional
Oversight Authority:
  • Norway: Norwegian Medicines Agency
  • United States: Food and Drug Administration
  • European Union: European Medicines Agency
  • Canada: Health Canada
Collaborators:
Brief Summary: The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).
Detailed Description:
Record Verification Date: March 2011
Status: Completed
Why Study Stopped:
Study Start Date: July 2005
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject: no
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their VMR (vasomotor rhinitis) symptoms.
Secondary Outcomes:
  • Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes this overall evaluation of response to therapy during the last clinic visit.
Conditions:
  • Rhinitis, Vasomotor
Keywords:
  • nonallergic rhinitis
  • vasomotor rhinitis
  • GW685698X
  • VMR
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 12 Year
Maximum Age:
Enrollment: 350
Enrollment Type:
Healthy Volunteers?: none
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
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