Special Drug Use Investigation for ALLERMIST (Long Term)

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01420822
• Collaborator: (none)
• Enrollment: 500
• Duration (Months): 44

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis	Drug: Fluticasone

Study Design

• Study Type: Observational
• Actual Enrollment: 500 participants
• Time Perspective: Prospective
• Official Title: Special Drug Use Investigation for ALLERMIST (Long Term)
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Subjects prescribed ALLERMIST Subjects with allergic rhinitis prescribed ALLERMIST during study period	Drug: Fluticasone; Collection of safety data

Outcome Measures

Primary Outcome Measures

1. The number of incidence of adverse events in Japanese subjects treated with ALLERMIST Nasal Spray for long-term use [One year]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01420822
• Other Study ID Numbers: 113406
• First Posted: Aug 22, 2011
• Last Update Posted: Mar 27, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Rhinitis; Fluticasone

Study Results

No Results Posted as of Mar 27, 2015