Last updated: 11/07/2018 06:04:47

Drug Use Investigation for ALLERMIST

GSK study ID
113407
See study documents
Clinicaltrials.gov ID
NCT01376206
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Drug Use Investigation for ALLERMIST
Trial description: 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: Four weeks

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fluticasone
    • Enrollment:
    2000
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Other
    Clinical publications:
    Keisuke Masuyama, Yoriko Morioka, Terufumi Hara. Drug Use Investigation on Fluticasone Furoate (Allermist®) 27.5 µg 56 Metered Nasal Spray. Allergol Immunol. 2012;19(12):88-101
    Medical condition
    Rhinitis
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    December 2009 to June 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    No
    • Diagnosis of allergic rhinitis
    • Use ALLERMIST for the first time
    • Subjects with infection which fluticasone is not effective
    • Subjects with deep mycosis
    Inclusion and exclusion criteria
    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 fluticason

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2012-22-06

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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