Special Drug Use Investigation for ALLERMIST (Long Term)

NCT ID: NCT01420822

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-08-31

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.

Conditions

Rhinitis

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects prescribed ALLERMIST

Subjects with allergic rhinitis prescribed ALLERMIST during study period

Fluticasone

Intervention Type: DRUG

Collection of safety data

Interventions

Fluticasone

Collection of safety data

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

113406

Identifier Type: -

Identifier Source: org_study_id