Special Drug Use Investigation for ALLERMIST (Long Term)

Completed

• Conditions: Rhinitis
• Interventions: Drug: Fluticasone

• Registration Number: NCT01420822
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This post-marketing surveillance study is to investigate possible problems or questions in safety and efficacy of ALLERMIST Nasal Spray for long-term use in Japanese subjects with allergic rhinitis under the conditions of actual practical use.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-22
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Diagnosis of allergic rhinitis
• Use ALLERMIST for the first time
• Expected to use ALLERMIST for long-term (1 year).

Exclusion Criteria

• Subjects with infection which fluticasone is not effective
• Subjects with deep mycosis
• Subjects with hypersensitivity to fluticasone

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects prescribed ALLERMIST	Fluticasone	Subjects with allergic rhinitis prescribed ALLERMIST during study period

Primary Outcome Measures

Name	Time	Method
The number of incidence of adverse events in Japanese subjects treated with ALLERMIST Nasal Spray for long-term use	One year
Efficacy evaluation based on the subjective/objective symptom progresses in the period from the start of Allermist treatment to the end of the observation period	One year