Special Drug Use Investigation for ALLERMIST (Long Term)

Rhinitis Clinical Trial

Official title:

Special Drug Use Investigation for ALLERMIST (Long Term)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420822
• Other study ID #: 113406
• Status: Completed
• Phase: N/A
• First received: June 2, 2011
• Last updated: March 26, 2015
• Start date: December 2010
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Rhinitis

Intervention

Drug:
• Fluticasone
Collection of safety data

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of incidence of adverse events in Japanese subjects treated with ALLERMIST Nasal Spray for long-term use		One year	No
Primary	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	No