Last updated: 11/24/2025 15:50:09
To Evaluate Real-World Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol (FF/UMEC/VI) in a Single Inhaler (Trelegy Ellipta) in Participants with Symptomatic COPD
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 12-week, prospective, open label, single cohort study to evaluate the real-world effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in a single inhaler (Trelegy Ellipta) in symptomatic chronic obstructive pulmonary disease (COPD) patients
Trial description: The primary objective of this study is to evaluate the effectiveness of TRELEGY ELLIPTA on health status in participants with symptomatic COPD. The secondary objective is to evaluate the effectiveness of TRELEGY ELLIPTA on dyspnea and lung function in participants with symptomatic COPD. TRELEGY and ELLIPTA are trademarks of the GlaxoSmithKline group of companies.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Change from baseline in COPD Assessment Test (CAT) score
Timeframe: Baseline (Day 1) and at Week 12
Secondary outcomes:
Change from baseline of Modified Medical Research Council (mMRC) Score
Timeframe: Baseline (Day 1) and at Week 12
Change from baseline in Pre-dose Forced Expiratory Volume in 1 second (FEV1)
Timeframe: Baseline (Day 1) and at Week 12
Percentage of participants having ≥ 2 unit decrease in CAT score from baseline at week 12.
Timeframe: Baseline (Day 1) and at Week 12
Number of participants with Trelegy related Adverse Events (AEs)
Timeframe: Up to Week 12
Number of participants with Serious Adverse Events (SAEs)
Timeframe: Up to Week 12
Number of participants with AEs that lead to the discontinuation of Trelegy Ellipta
Timeframe: Up to week 12
Interventions:
Enrollment:
463
Primary completion date:
2023-25-09
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Jinfang Ma, Fangfang Dou, Wutie Zhou, Liyu Li, Junfei Zhu, Yupeng Zhang, Luqian Zhou, Lin Su, Lu Dong, Yifan He, Ark Ye, David Slade, Jinping Zheng. Real-world effectiveness of single-inhaler fluticasone furoate/umeclidinium bromide/vilanterol in Chinese patients with symptomatic chronic obstructive pulmonary disease (COPD): a post-marketing, prospective, multicenter, observational study. Current medical research and opinion. 2025-Jul-24;: 1-14. doi:10.1080/03007995.2025.2536600 http://dx.doi.org/10.1080/03007995.2025.2536600
PMID: 40704458
DOI: 10.1080/03007995.2025.2536600
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
vilanterol
Collaborators
Not applicable
Study date(s)
October 2022 to September 2023
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Participant must be 40 years or above of age inclusive, at the time of signing the informed consent.
- Participants with a documented physician diagnosis of COPD.
- Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- Prescribed with Trelegy within one year prior to screening (Visit 1).
Inclusion and exclusion criteria
Inclusion criteria:
- Participant must be 40 years or above of age inclusive, at the time of signing the informed consent.
- Participants with a documented physician diagnosis of COPD.
- CAT greater than or equal to (≥) 10.
- Existing COPD Maintenance Treatment. Participants currently receiving one of the maintenance therapies given below who have been prescribed it continually for at least 12 weeks prior to screening (Visit 1): Inhaled Corticosteroids/ Long-Acting Beta-2-Agonists (ICS/LABA) (single or multiple inhalers); Long-Acting Muscarinic Antagonist (LAMA)/LABA (single or multiple inhalers); Free combination of inhaled corticosteroids (ICS), LAMA, LABA.
- Current or former cigarette smokers with a history of cigarette smoking history ≥10 pack-years at screening.
- Trelegy is prescribed under the discretion of clinical physicians with medical records providing documentation of a Trelegy prescription in daily practice.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria:
- Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- Prescribed with Trelegy within one year prior to screening (Visit 1).
- Participants who, in the opinion of the treating investigator, are chronic users of oral corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening). Chronic use is defined as more than 14 days continuous use during the 12 weeks prior to Visit 1.
- Participants with any life-threatening condition i.e. low probability, in the opinion of the investigator, of 3-month survival due to severity of COPD or comorbid condition.
- Participants with unstable COPD. Participants with resolution of an exacerbation less than 2 weeks prior to Visit 1. Participants may be rescreened 2 weeks after resolution of exacerbation (exacerbation is defined as: requiring treatment with antibiotics and/or systemic steroids or hospitalization; resolution is defined as: 2 weeks after all symptoms have resolved and any medicines to treat the exacerbation have finished).
- Participants who need more than 3 liter per minute (L/min) supplemental oxygen at rest at screening.
- Other diseases/abnormalities: Participants with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
- Participant received any investigational drug in other clinical trial within four weeks or 5 half-lives prior to this study whichever is longer.
- Any conditions or illnesses listed in the section of contraindications in the Summary of Product Characteristics (SmPC) of Trelegy, i.e., hypersensitivity to the active substances of TRELEGY ELLIPTA.
- Participants with known COVID-19 positive contacts within the past 14 days.
- Inability to read: In the opinion of the Investigator, any participant who is unable to read and/or would not be able to complete study related materials.
Trial location(s)
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2023-25-09
Actual study completion date
2023-25-09
Plain language summaries
Summary of results in plain language
Available language(s): English, Chinese (Simplified)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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