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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2020-03-06
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)

No location data available.

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
Finalized
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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