Last updated: 07/28/2020 03:50:15

A post-marketing surveillance study of AvamysTM (Fluticasone furoate) in the treatment of Filipino patients with Allergic Rhinitis (AR)Avamys PMS

GSK study ID
115312
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: A post-marketing surveillance study of AvamysTM (Fluticasone furoate) in the treatment of Filipino patients with Allergic Rhinitis (AR)
Trial description: This is a regulatory manadated post marketing surveillance study for all products under monitored release in the Philippines.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Adverse event reports

Timeframe: within two weeks of use

Secondary outcomes:

None

Timeframe: None

Interventions:
  • Drug: Avamys
    • Enrollment:
    421
    Primary completion date:
    2013-08-01
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Joselito C. Javier, Sheila C. Chua, Giovell P. Barangan.Safety of Fluticasone Furoate Nasal Spray Among Filipino Patients with Allergic Rhinitis: A Post-Marketing Surveillance Study.Philipp J Intern Med.2018;56(1):48-55
    Medical condition
    Rhinitis, Allergic, Perennial and Seasonal
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    August 2010 to January 2013
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    2 - 80 Year
    Accepts healthy volunteers
    none
    • Patients (pediatric starting at two years and above; and adults) with clinically diagnosed Allergic Rhinitis (AR)
    • Patients must give written informed consent to take part in the study (for pediatric patients, then the parent or legal guardian should give the consent)
    • Patients with known hypersensitivity to Fluticasone furoate or any component of the preparation
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients (pediatric starting at two years and above; and adults) with clinically diagnosed Allergic Rhinitis (AR)
    • Patients must give written informed consent to take part in the study (for pediatric patients, then the parent or legal guardian should give the consent)
    • As per recommendation of Avamys™ (Fluticasone furoate) prescribing information
    Exclusion criteria:
    • Patients with known hypersensitivity to Fluticasone furoate or any component of the preparation

    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
    2013-08-01
    Actual study completion date
    2013-08-01

    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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