Last updated: 12/06/2024 09:01:36

A Post-Marketing Surveillance (PMS) Study to Monitor the Safety and Effectiveness of Trelegy 200 Ellipta Administered in Korean Participants in Real-world Practice

GSK study ID
219293
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 Trelegy 200 Ellipta administered in Korean subjects in real-world practice
Trial description: The goal of this observational study is to collect the safety and effectiveness data on Trelegy 200 Ellipta administered in Korean participants with asthma in a real-world setting.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Percentage of Participants with Adverse Events (AEs) / Adverse Drug Reactions (ADRs)

Timeframe: Up to 12 weeks

Percentage of Participants with Unexpected AEs / ADRs

Timeframe: Up to 12 weeks

Percentage of Participants with Serious Adverse Events (SAEs) / Serious Adverse Drug Reactions (SADRs)

Timeframe: Up to 12 weeks

Secondary outcomes:

Physician’s Global Assessment

Timeframe: At week 12

Mean Change in Asthma Control Test Scores as per Global Initiative for Asthma (GINA) Guidelines

Timeframe: Up to 12 weeks

Rate of Asthma Exacerbation

Timeframe: Up to 12 weeks

Interventions:
Not applicable
Enrollment:
86
Primary completion date:
2024-20-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
March 2024 to June 2024
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
19+ years
Accepts healthy volunteers
No
  • Participants receiving maintenance treatment of asthma who are not adequately controlled with a combination of inhaled corticosteroid and a long-acting beta 2-agonist
  • Participants who will be administered Trelegy 200 Ellipta in accordance with the product information approved in Korea
  • Participants who have hypersensitivity of Trelegy 200 Ellipta or components of Trelegy 200 Ellipta
  • Participants who have severe hypersensitivity to milk proteins
Inclusion and exclusion criteria
Inclusion criteria:

    •Participants receiving maintenance treatment of asthma who are not adequately controlled with a combination of inhaled corticosteroid and a long-acting beta 2-agonist •Participants who will be administered Trelegy 200 Ellipta in accordance with the product information approved in Korea

Exclusion criteria:

    •Participants who have hypersensitivity of Trelegy 200 Ellipta or components of Trelegy 200 Ellipta •Participants who have severe hypersensitivity to milk proteins •Participants who have genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Wonju-City, South Korea, 26426
Status
Study Complete
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Location
GSK Investigational Site
Seoul, South Korea, 07804
Status
Study Complete
Contact us

Study documents

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
2024-20-06
Actual study completion date
2024-20-06

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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