Last updated: 02/03/2020 18:10:06

Drug Use Investigation of RELVAR® (vilanterol trifenatate and fluticasone furoate) for Asthma Patients

GSK study ID
200293
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: Drug Use Investigation of RELVAR® (vilanterol trifenatate and fluticasone furoate) for Asthma Patients
Trial description: This is a post-marketing surveillance (PMS) study conducted in Japan. The purpose of this investigation is to collect and evaluate information on the safety and effectiveness of vilanterol trifenatate and fluticasone furoate in routine clinical practice. RELVAR 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:

Occurrence of adverse drug reactions and infections in routine clinical practice.

Timeframe: 12 weeks

Total scores of Athma Control Test

Timeframe: 12 weeks

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Vilanterol trifenatate and fluticasone furoate
    • Enrollment:
    908
    Primary completion date:
    2015-20-01
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Junko Minami, Isao Mukai, Akihiro Kobayashi, Terufumi Hara,Hironori Sagara.Safety and Effectiveness of Vilanterol Trifenatate/Fluticasone Furoate Dry-Powder Inhaler (Relvar® Ellipta®) in Patients with Bronchial Asthma: Results of Drug Use Investigation.Ther Res.2015;36(5):455-467
    Medical condition
    Asthma
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    December 2013 to January 2015
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Patients with asthma
    • Patients who are treated with vilanterol trifenatate and fluticasone furoate for the first time
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients with asthma
    • Patients who are treated with vilanterol trifenatate and fluticasone furoate for the first time
    Exclusion criteria:
    • None

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    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
    2015-20-01
    Actual study completion date
    2015-20-01

    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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