Special Drug Use Investigation for ALLERMIST (Long Term)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01420822

Enrollment

500

Registered

2011-08-22

Start date

2010-12-31

Completion date

2014-08-31

Last updated

2015-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis

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.

Interventions

DRUGFluticasone

Collection of safety data

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026