Last updated: 01/18/2023 15:31:33

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

GSK study ID
204511
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: An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of ANORO administered in Korean subjects with chronic obstructive pulmonary disease (COPD) in usual practice
Trial description: ANORO has been approved on 10, July, 2014 in Korea. We aimed to conduct PMS to monitor the safety and effectiveness based on the data collected in a real world clinical practice according to PMS regulation.
Surveillance period (planned) : 01.October.2015~09 July.2020
Submission period of application form for PMS : 10 July.2020 ~ 09 October.2020
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Minimum one follow-up after administrating ANORO for safety evaluation

Timeframe: minimum one follow up

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
3000
Primary completion date:
2020-24-07
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Cho E-Y, Cho J-E, Lee E-B, Yoo SS, Chang JH.An open-label, multicentre, observational, post-marketing study to monitor the safety and effectiveness of umeclidinium/vilanterol in Korean patients.Tuberc Respir Dis (Seoul).2022; DOI: 10.4046/trd.2022.0055
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, vilanterol, umeclidinium bromide/vilanterol
Collaborators
Not applicable
Study date(s)
October 2015 to July 2020
Type
Observational
Phase
4

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)
  • Pulmonary Function Test: post bronchodilator, FEV1/FVC < 0.7
  • Asthma patient
  • Subject with acute exacerbation of COPD
Inclusion and exclusion criteria
Inclusion criteria:
  • Adult subjects (19 years and older) who have chronic obstructive pulmonary disease (COPD)
  • Pulmonary Function Test: post bronchodilator, FEV1/FVC < 0.7 Subjects who will administer ANORO according to locally approved prescribing information
Exclusion criteria:
  • Asthma patient
  • Subject with acute exacerbation of COPD
  • Subject who experienced hypersensitivity to the active substances or to any of the excipients
  • Subject with severe hypersensitivity to milk proteins
  • Subject with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
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
2020-24-07
Actual study completion date
2020-24-07

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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