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CompletedNCT01420822Updated Mar 27, 2015

Special Drug Use Investigation for ALLERMIST (Long Term)

An observational study in Rhinitis, sponsored by GlaxoSmithKline. Completed. Per ClinicalTrials.gov, last updated 2015-03-27.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
500
Sex
All
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Study 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.

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Conditions studied

  • Rhinitis

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03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 500 is above the median of 141 across 172 observational studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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).

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Time perspective
Prospective
Enrollment
500 participants (actual)

Groups and cohorts

  • Subjects prescribed ALLERMIST

    Subjects with allergic rhinitis prescribed ALLERMIST during study period

    Drug: Fluticasone

Interventions

  • DrugFluticasone

    Collection of safety data

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What researchers measure

Primary outcomes

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

    Time frame: 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

    Time frame: One year

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01420822
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 22, 2011
Start date
Dec 2010
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Mar 27, 2015

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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