NCT01420822

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

3.7 years

First QC Date

June 2, 2011

Last Update Submit

March 26, 2015

Conditions

Rhinitis

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Subjects prescribed ALLERMIST

Subjects with allergic rhinitis prescribed ALLERMIST during study period

Drug: Fluticasone

Interventions

FluticasoneDRUG

Collection of safety data

Subjects prescribed ALLERMIST

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The target subjects shall be those who with allergic rhinitis for which the indication of ALLERMIST has been approved and who are using ALLERMIST for the first time and also who are expected to use ALLERMIST for long-term (1 year).

You may qualify if:

  • Diagnosis of allergic rhinitis
  • Use ALLERMIST for the first time
  • Expected to use ALLERMIST for long-term (1 year).

You may not qualify if:

  • Subjects with infection which fluticasone is not effective
  • Subjects with deep mycosis
  • Subjects with hypersensitivity to fluticasone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2011

First Posted

August 22, 2011

Study Start

December 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 27, 2015

Record last verified: 2015-03