Last updated: 07/31/2020 14:30:05

Special Drug Use Investigation of ALLERMIST Nasal Spray in Pediatric Patients

GSK study ID
200585
See study documents
Clinicaltrials.gov ID
Not applicable
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 of ALLERMIST Nasal Spray in Pediatric Patients
Trial description: This post-marketing surveillance(PMS)study is conducted to collect safety and effectiveness data in pediatric patients with allergic rhinitis who are treated with fluticasone nasal spray for the first time. ALLERMIST is a registered trademark of the GSK group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The incidence of adverse drug reactions

Timeframe: 24 weeks

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fluticasone nasal spray
    • Enrollment:
    1000
    Primary completion date:
    2017-31-10
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Yasuyo Nose, Yoshifumi Inagaki,Hirohiko Murayama,Kiyomi Aizawa,Terufumi Hara,Wataru Sugiura. Safety and efficacy evaluation of fluticasone furoate (ALLERMIST) nasal spray in pediatric patients with allergic rhinitis Special drug use investigation results. Jpn J Pediatr. 2018;71(11):109-121
    Medical condition
    Rhinitis, Allergic, Perennial and Seasonal
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    October 2014 to October 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    - 15 Years
    Accepts healthy volunteers
    Not applicable
    • Inclusion Criteria
    • Subjects with allergic rhinitis
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria
    • Subjects with allergic rhinitis
    • Subjects who are treated with fluticasone nasal spray for the first time
    • Subjects who are under 15 years of age Exclusion Criteria
    • none

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    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
    2017-31-10
    Actual study completion date
    2017-31-10

    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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