Last updated: 12/05/2025 11:00:13
TRELEGY® general drug use investigation (asthma)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Trelegy Ellipta General Drug Use Investigation (asthma)
Trial description: This study will be conducted to collect and assess information regarding the safety and effectiveness of TRELEGY ELLIPTA® in participants diagnosed with bronchial asthma under actual use conditions. TRELEGY ELLIPTA 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 cardiovascular events
Timeframe: Up to 1 year
Number of participants with adverse drug reactions (ADRs) and infections
Timeframe: Up to 1 year
Percentage of participants with ADRs and infections
Timeframe: Up to 1 year
Percentage of participants assessed as effective
Timeframe: Up to 1 year
Secondary outcomes:
Change from Baseline in forced expiratory volume in one second (FEV1) and forced vital capacity (FVC)
Timeframe: Baseline and up to 1 year
Change from Baseline in Peak Expiratory Flow (PEF)
Timeframe: Baseline and 1, 3, 6 months and 1 year
Change from Baseline in asthma control test score
Timeframe: Baseline and 1, 3, 6 months and 1 year
Change from Baseline in asthma control status
Timeframe: Baseline and 1, 3, 6 months and 1 year
Percentage of participants with events related to exacerbation of asthma
Timeframe: Up to 1 year
Interventions:
Not applicable
Enrollment:
300
Primary completion date:
2024-31-07
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Kazuhisa A, Morioka Y, Ito R, Komatsubara M, Maruoka H. Real-World Safety and Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Asthma: Final Analysis of a Post Marketing Surveillance in Japan. Adv Ther. 2025; doi:10.1007/s12325-025-03421-2 https://link.springer.com/article/10.1007/s12325-025-03421-2
PMID: 41313548
DOI: 10.1007/s12325-025-03421-2
Medical condition
Asthma
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
July 2021 to July 2024
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
15+ years
Accepts healthy volunteers
No
- Participants who will be prescribed TRELEGY for the first time for the treatment of bronchial asthma.
- Participants should be capable of giving informed consent.
- Not applicable.
Inclusion and exclusion criteria
Inclusion criteria:
- Participants who will be prescribed TRELEGY for the first time for the treatment of bronchial asthma.
- Participants should be capable of giving informed consent.
Exclusion criteria:
- Not applicable.
Trial location(s)
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
2024-31-07
Actual study completion date
2024-31-07
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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