Last updated: 12/06/2024 09:30:28
Post-marketing surveillance (PMS) study of TRELEGY® administered in participants with chronic obstructive pulmonary disease (COPD) in a real-world settingTRELEGY
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 to observe the safety and effectiveness of Trelegy administered in patients with chronic obstructive pulmonary disease (COPD) in a real-world setting
Trial description: This PMS study will collect safety and effectiveness data on TRELEGY’s approved label in a real-world setting. TRELEGY is a registered trademark of GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with adverse events (AEs), unexpected AEs, adverse drug reactions (ADRs), unexpected ADRs, serious adverse events (SAEs) and serious adverse drug reaction (SADRs)
Timeframe: Upto 52 weeks
Severity of AEs
Timeframe: Up to 52 weeks
Number of AEs having causal relationship with TRELEGY
Timeframe: Up to 52 weeks
Physicians’ comprehensive effectiveness assessment results of TRELEGY
Timeframe: Up to 52 weeks
Change from Baseline in Pulmonary Function Test
Timeframe: Baseline and up to 52 weeks
Number of Participants with moderate to severe COPD exacerbations
Timeframe: Baseline and up to 52 weeks
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
600
Primary completion date:
2024-20-06
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
vilanterol
Collaborators
NA
Study date(s)
July 2021 to June 2024
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
19+ years
Accepts healthy volunteers
No
- COPD participants older than 19 years of age.
- Participants who will administer TRELEGY in accordance with the product information approved in Korea.
- Participants who have hypersensitivity of TRELEGY or components of TRELEGY.
- Participants who are severely hypersensitive to milk proteins.
Inclusion and exclusion criteria
Inclusion criteria:
- COPD participants older than 19 years of age.
- Participants who will administer TRELEGY in accordance with the product information approved in Korea.
- Participants who have signed the Participant Information Sheet/Consent Form for the PMS.
Exclusion criteria:
- Participants who have hypersensitivity of TRELEGY or components of TRELEGY.
- Participants who are severely hypersensitive to milk proteins.
- Participants who have genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
Trial location(s)
Showing 1 - 6 of 10 Results
Study documents
Protocol
Available language(s): English
Statistical analysis plan
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
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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