Last updated: 11/07/2018 04:37:41

Special Drug Use Investigation for ADOAIR (fluticasone/salmeterol)

GSK study ID
112278
See study documents
Clinicaltrials.gov ID
NCT01395862
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 ADOAIR (fluticasone/salmeterol)
Trial description: The purpose of this study is to detect adverse drug reactions for long-term use (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy in the Japanese asthma patients who are treated with fluticasone propionate/salmeterol xinafoate.
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 asthma patients treated with fluticasone and salmeterol for long-term

Timeframe: 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Salmeterol and Fluticasone
    • Enrollment:
    1001
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Rie Otake, Junko Minami, Terufumi Hara, Pascal Yoshida.Post-Marketing Surveillance of Salmeterol Xinafoate /Fluticasone Propionate in Asthma Patients with Long-Term Administration.J Clin Therapeut Med.2014;30(4):303-318
    Medical condition
    Respiratory Disorders
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    November 2007 to September 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    No
    • Must use fluticasone and salmeterol for the first time
    • Must use fluticasone and salmeterol for long-term
    • Patients with hypersensitivity to salmeterol and fluticasone
    • Patients with infection which salmeterol and fluticasone is not effective
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Must use fluticasone and salmeterol for the first time
    • Must use fluticasone and salmeterol for long-term
    Exclusion criteria:
    • Patients with hypersensitivity to salmeterol and fluticasone
    • Patients with infection which salmeterol and fluticasone is not effective
    • Patients with deep mycosis

    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
    2012-28-09

    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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