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Home > Protocol Summaries: Compounds > fluticasone furoate > Protocol Summary for 113596

Protocol Summary for 113596

Protocol Summary
Protocol Id: 113596
Secondary Ids:
  • N/A
Title: An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Avamys® administered in Korean patients according to the prescribing information
Phase: phase 4
Acronym:
FDA Regulated Intervention?: No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Observational
Oversight Authority:
  • Korea Food And Drug Administration
Collaborators:
  • N/A
Brief Summary: Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Avamys® administered in Korean patients according to the prescribing information
Detailed Description:
Record Verification Date: May 2012
Status: Recruiting
Why Study Stopped:
Study Start Date: May 2010
Estimated Study Completion Date: May 2014
Study Completion Date Type: Anticipated
Estimated Primary Completion Date: May 2014
Primary Completion Date Type: Anticipated
Study Design: Other
Time Perspective: Prospective
Biospecimen Retention: None retained
Biospecimen Description: n/a
Primary Outcomes:
  • Number of participants with an adverse event yes 2weeks
Secondary Outcomes:
  • Number of participants with an unexpected adverse event yes 2weeks
  • Number of participants with a serious adverse event yes 2weeks
Conditions:
  • Rhinitis, Allergic, Perennial and Seasonal
Keywords:
  • avamys
  • Allergic Rhinitis
  • post marketing surveillance
  • Seasonal Allergic Rhinitis
  • Perennial Allergic Rhinitis (PAR)
  • rhinitis
Study Population: Patients administrated Avamys at the site
Sampling Method: Probability
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 2 Year
Maximum Age:
Enrollment: 3000
Enrollment Type: Anticipated
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: No locations currently recruiting for this study.