Drug Use Investigation for ALLERMIST

Completed

• Conditions: Rhinitis
• Interventions: Drug: Fluticasone

• Registration Number: NCT01376206
• Lead Sponsor: GlaxoSmithKline

Brief Summary

To investigate possible problems or questions in safety and efficacy of ALLERMIST Nasal Spray in Japanese subjects with allergic rhinitis under the practical use conditions

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2010-09
• Study Completion: 2011-05
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-20
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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 fluticason

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 adverse events in Japanese subjects with allergic rhinitis treated with fluticasone nasal spray	Four weeks