Last updated: 11/24/2020 11:00:04

ENCRUSE ELLIPTA Drug Use Investigation

GSK study ID
201450
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: ENCRUSE ELLIPTA Drug Use Investigation
Trial description: This post-marketing surveillance (PMS) study is conducted to collect safety and effectiveness data in subjects with chronic obstructive pulmonary disease (COPD) who are treated with umeclidinium bromide to relief the symptoms of obstructive airway disorder and who are naive to the drug. ENCRUSE and ELLIPTA are 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: 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: umeclidinium bromide
    • Enrollment:
    1091
    Primary completion date:
    2019-29-11
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Sakata K, Yoshida M, Kaneuchi A, Ishii T, Hara T. Evaluation of Safety and Effectiveness of Umeclidinium Bromide Dry Powder Inhaler in Chronic Obstructive Pulmonary Disease (COPD) - Final Report of Drug Use Investigation -. Prog Med. 2020;40:1079-1091
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    umeclidinium bromide
    Collaborators
    Not applicable
    Study date(s)
    April 2016 to November 2019
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    None
    • Subjects with chronic obstructive pulmonary disease
    • Subjects who are treated with umeclidinium bromide for the first time
    • none
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with chronic obstructive pulmonary disease
    • Subjects who are treated with umeclidinium bromide for the first time
    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
    2019-29-11
    Actual study completion date
    2019-29-11

    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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