NCT01001130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,244

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 30, 2014

Status Verified

June 1, 2014

Enrollment Period

4 years

First QC Date

October 22, 2009

Last Update Submit

June 26, 2014

Conditions

Rhinitis, Allergic, Perennial and Seasonal

Keywords

avamysAllergic Rhinitispost marketing surveillanceSeasonal Allergic RhinitisPerennial Allergic Rhinitis (PAR)

Outcome Measures

Primary Outcomes (1)

  • Number of participants with an adverse event

    Number of participants with an adverse event

    2 weeks

Secondary Outcomes (3)

  • Number of participants with a serious adverse event

    2 weeks

  • Number of participants with an unexpected or expected adverse drug reaction

    2 weeks

  • Effectiveness after AVAMYS nasal spray administration

    2 weeks

Study Arms (1)

fluticasone furoate group

Korean patients administered fluticasone furoate according to the Prescription information

Drug: fluticasone furoate group

Interventions

fluticasone furoate groupDRUG

patients who are administered fluticasone furoate at least once

Also known as: according to label and physician's decision
fluticasone furoate group

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients administrated AVAMYS nasal spray at the site

You may not qualify if:

  • All subjects must not satisfy the following criteria.
  • Subject who has hypersensitivity to its ingredients.
  • As corticosteroids can slow the healing of wounds, if a subject who has surgery on his/her nose recently, or has a sore in his/her nose, or if his/her nose has been injured, the subject does not use AVAMYS nasal spray until his/her nose has healed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Seongnam-si Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

RhinitisRhinitis, AllergicRhinitis, Allergic, SeasonalRhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2009

First Posted

October 23, 2009

Study Start

May 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 30, 2014

Record last verified: 2014-06

Locations

KR(1)