NCT01376206

Brief Summary

To investigate possible problems or questions in safety and efficacy of ALLERMIST Nasal Spray in Japanese subjects with allergic rhinitis under the practical use conditions

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2009

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, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
Last Updated

May 22, 2017

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

June 9, 2011

Last Update Submit

May 19, 2017

Conditions

Rhinitis

Outcome Measures

Primary Outcomes (1)

  • The number of adverse events in Japanese subjects with allergic rhinitis treated with fluticasone nasal spray

    Four weeks

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 MethodNon-Probability Sample
Study Population

Subjects who have allergic rhinitis for which the indication of ALLERMIST has been approved and who are using ALLERMIST for the first time.

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 fluticason

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
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 20, 2011

Study Start

December 1, 2009

Primary Completion

September 1, 2010

Study Completion

May 1, 2011

Last Updated

May 22, 2017

Record last verified: 2017-05