Last updated: 11/07/2018 06:04:31

Special Drug Use Investigation for ALLERMIST (Long term)

GSK study ID
113406
See study documents
Clinicaltrials.gov ID
NCT01420822
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: Special Drug Use Investigation for ALLERMIST (Long term)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: 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

Timeframe: One year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fluticasone
    • Enrollment:
    500
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Yanagita,Y; Nakano,N; Hara,T; Yoshida,P . Long-term Safety and Effectiveness of Fluticasone Furoate (Allermist®) Nasal Spray in Patients with Perennial Allergic Rhinitis: Results of Special Drug Use Investigation. J Clin Therapeut Med. 2015;31(11):
    Medical condition
    Rhinitis
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    December 2010 to August 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    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 fluticasone

    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
    2014-29-08

    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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