Regulatory AVAMYS Nasal Spray PMS

Completed

• Conditions: Rhinitis, Allergic, Perennial and Seasonal
• Interventions: Drug: fluticasone furoate group

• Registration Number: NCT01001130
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of AVAMYS nasal spray administered in Korean patients according to the prescribing information.

AVAMYS is a registered trademark of the GSK group of companies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Study Start: 2010-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-26
• Last Update Posted: 2014-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3244

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
fluticasone furoate group	fluticasone furoate group	Korean patients administered fluticasone furoate according to the Prescription information

Primary Outcome Measures

Name	Time	Method
Number of participants with an adverse event	2 weeks	Number of participants with an adverse event

Secondary Outcome Measures

Name	Time	Method
Number of participants with a serious adverse event	2 weeks	Number of participants with a serious adverse event
Number of participants with an unexpected or expected adverse drug reaction	2 weeks	Number of participants with an unexpected or expected adverse drug reaction
Effectiveness after AVAMYS nasal spray administration	2 weeks	Effectiveness after AVAMYS nasal spray administration

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Seongnam-si Gyeonggi-do, Korea, Republic of