Last updated: 04/21/2023 14:29:41

An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of INCRUSE administered in Korean subjects with chronic obstructive pulmonary disease (COPD) in usual practice

GSK study ID
205163
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: An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of INCRUSE administered in Korean subjects with chronic obstructive pulmonary disease (COPD) in usual practice
Trial description: INCRUSE (umeclidinium bromide) is a long-acting muscarinic receptor antagonist in development as an orally inhaled product for the treatment of COPD. Its use was approved on the 25th of June 2015 in Korea. The current study is a post marketing surveillance to monitor its safety and efficacy based on the data collected in a ‘real-world’ clinical practice.
The primary objective of this study is to monitor adverse events; the secondary objective is to monitor efficacy. Subjects will use the INCRUSE as per their prescription, in an open-label manner. This study is observational in nature, and will not alter the subject’s prescription or standard of care. The investigator will follow-up at least once with each subject, after the subject has received at least one dose of INCRUSE, for the safety evaluation. Efficacy will be assessed by a 24-week follow-up. Each subject will be monitored for a maximum of 6 months.
INCRUSE is a registered trademark of the GlaxoSmithKline Group of Companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects with adverse events

Timeframe: 6 months

Number of subjects with unexpected adverse events

Timeframe: 6 months

Number of subjects with serious adverse events

Timeframe: 6 months

Secondary outcomes:

Physician’s evaluation of subject’s health, on a 4-point scale, based on post-bronchodilator forced expiratory volume in 1 second (FEV1) at the end of 24 weeks

Timeframe: Week 24

Interventions:
  • Other: Case Report Form
  • Drug: INCRUSE (umeclidinium bromide)
  • Enrollment:
    600
    Primary completion date:
    2020-03-06
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Asthma Chronic Obstructive Pulmonary Disease Overlap Syndrome, Pulmonary Disease, Chronic Obstructive
    Product
    umeclidinium bromide
    Collaborators
    Not applicable
    Study date(s)
    August 2016 to June 2020
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    19+ years
    Accepts healthy volunteers
    Not applicable
    • Adult subjects (19 years and older) who have chronic obstructive pulmonary disease (COPD)
    • Subjects who will administer INCRUSE according to locally approved prescribing information
    • Subject who has medical history of hypersensitivity to the active substances or main substances or atropine derivative (that is, ipratropium,tiotropium, oxitropium, glycopyrronium, aclidinium)
    • Subject with severe hypersensitivity to milk proteins

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Study report synopsis
    Available language(s): English
    Clinical study report
    Available language(s): English
    Protocol
    Available language(s): English
    Scientific result summary
    Available language(s): English

    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
    2020-03-06
    Actual study completion date
    2020-03-06

    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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