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Regulatory AVAMYS Nasal Spray PMS

NCT ID: NCT01001130

Last Updated: 2014-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3244 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-05-31

Brief Summary

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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

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Conditions

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Rhinitis, Allergic, Perennial and Seasonal

Keywords

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avamys Allergic Rhinitis post marketing surveillance Seasonal Allergic Rhinitis Perennial Allergic Rhinitis (PAR)

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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fluticasone furoate group

Korean patients administered fluticasone furoate according to the Prescription information

fluticasone furoate group

Intervention Type DRUG

patients who are administered fluticasone furoate at least once

Interventions

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fluticasone furoate group

patients who are administered fluticasone furoate at least once

Intervention Type DRUG

Other Intervention Names

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according to label and physician's decision

Eligibility Criteria

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Exclusion Criteria

All subjects must not satisfy the following criteria.

1. Subject who has hypersensitivity to its ingredients.
2. 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.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Seongnam-si Gyeonggi-do, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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113596

Identifier Type: -

Identifier Source: org_study_id