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
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
Enrollment:
600
Primary completion date:
2020-03-06
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
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
Inclusion and exclusion criteria
Inclusion criteria:
- Adult subjects (19 years and older) who have chronic obstructive pulmonary disease (COPD)
- Subjects who will administer INCRUSE according to locally approved prescribing information
Exclusion criteria:
- 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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