Pulmonary Disease, Chronic ObstructivePhase 4NCT05535972
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
A Phase 4 study testing FF/UMEC/VI in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- FF/UMEC/VI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 463 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2022to 25 Sep 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- FF/UMEC/VI
- Keywords
- TRELEGY ELLIPTA, Single Inhaler, Fluticasone Furoate, Umeclidinium Bromide, Vilanterol, FF/UMEC/VI
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FF/UMEC/VIDrug
Also called TRELEGY ELLIPTA
FF/UMEC/VI will be administered in a single inhaler Trelegy Ellipta.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving TRELEGY ELLIPTA | Experimental | Participants will receive FF/UMEC/VI, inhalation powder, once daily, in a single device (TRELEGY ELLIPTA) for 12 weeks. Receives: Drug: FF/UMEC/VI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in COPD Assessment Test (CAT) Score at Week 12
The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value.
Measured: Baseline (Day 1, pre-dose) and at Week 12
Secondary outcomes (8)
Change From Baseline in Modified Medical Research Council (mMRC) Grading System at Week 12 (Patient Version)
mMRC(Patient Version[Pt.V]) was used to assess breathlessness state of participant before and after treatment. mMRC (Pt V) was completed by each participant firstly, without supervision.Participants were scored on a scale of 0 (no impact) to 4(worst possible impact) depending on their disability due to shortness of breath. Higher scores indicated greater disease impact;where 0=only get breathless with strenuous exercise;1=get short of breath when hurrying on the level/walking up a slight hill;2=walk slower than people of same age on the level because of breathlessness/have to stop for breath when walking at own pace on the level;3=stop for breath after walking about 100 yards/after a few minutes on the level;4=too breathless to leave house/breathless when dressing. Baseline=latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline=post-dose visit value minus Baseline value.
Measured: Baseline (Day 1, pre-dose) and at Week 12
Change From Baseline in Modified Medical Research Council (mMRC) Dyspnea Scale at Week 12 (Physician Version)
mMRC(Physician Version[PV]) was used to assess breathlessness state of participant before and after treatment. Physicians completed mMRC(PV) through their observation. Participants were scored on a scale of 0 (no impact) to 4(worst possible impact) depending on their disability due to shortness of breath. Higher scores indicated greater disease impact; where 0=no breathlessness except on strenuous exercise; 1=shortness of breath when hurrying on the level ground or walking up a slight hill; 2=walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3=stops for breath after walking about 100 yards or after few minutes on level ground; 4=too breathless to leave house or breathless when dressing or undressing. Baseline=latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline=post-dose visit value minus Baseline value.
Measured: Baseline (Day 1, pre-dose) and at Week 12
Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) at Week 12
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Measured: Baseline (Day 1, pre-dose) and at Week 12
Percentage of Participants Having >=2 Unit Decrease in CAT Score From Baseline at Week 12
The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Percentage values are rounded-off. Percentage of participants having >=2 unit decrease in CAT score from Baseline at week 12 has been presented.
Measured: Baseline (Day 1, pre-dose) and at Week 12
Change From Baseline in COPD Assessment Test (CAT) Score at Week 4
The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value.
Measured: Baseline (Day 1, pre-dose) and at Week 4
Number of Participants With Trelegy Related Non-serious Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Measured: Up to 251 days
Number of Participants With Trelegy Related Serious Adverse Events (SAEs)
A SAE is defined as any serious adverse event that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, a suspected transmission of any infectious agent via an authorized medicinal product or other situations as judged by physician.
Measured: Up to 251 days
Number of Participants With Trelegy Related AEs Leading to the Discontinuation
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Measured: Up to 251 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start14 Oct 2022
- Primary completion25 Sep 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535972
- Sponsor's protocol ID
- 217658
- Status last verified
- Nov 2025
- First submitted
- 7 Sep 2022
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Publications
Ma J, Dou F, Zhou W, Li L, Zhu J, Zhang Y, Zhou L, Su L, Dong L, He Y, Ye A, Slade D, Zheng J. 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. Curr Med Res Opin. 2025 Jul;41(7):1363-1372. doi: 10.1080/03007995.2025.2536600. Epub 2025 Jul 29.
PubMed 40704458
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05535972
- Acronym / sponsor ID
- 217658
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- TRELEGY ELLIPTA, Single Inhaler, Fluticasone Furoate, Umeclidinium Bromide, Vilanterol, FF/UMEC/VI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Posted 4 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving TRELEGY ELLIPTA | Experimental | Drug: FF/UMEC/VIParticipants will receive FF/UMEC/VI, inhalation powder, once daily, in a single device (TRELEGY ELLIPTA) for 12 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FF/UMEC/VIAlso: TRELEGY ELLIPTAFF/UMEC/VI will be administered in a single inhaler Trelegy Ellipta. | Drug | Participants receiving TRELEGY ELLIPTA |
Primary outcome
Change From Baseline in COPD Assessment Test (CAT) Score at Week 12
Time frame: Baseline (Day 1, pre-dose) and at Week 12
The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value.
8 secondary outcomes
Change From Baseline in Modified Medical Research Council (mMRC) Grading System at Week 12 (Patient Version)
Time frame: Baseline (Day 1, pre-dose) and at Week 12
Change From Baseline in Modified Medical Research Council (mMRC) Dyspnea Scale at Week 12 (Physician Version)
Time frame: Baseline (Day 1, pre-dose) and at Week 12
Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Time frame: Baseline (Day 1, pre-dose) and at Week 12
Percentage of Participants Having >=2 Unit Decrease in CAT Score From Baseline at Week 12
Time frame: Baseline (Day 1, pre-dose) and at Week 12
Change From Baseline in COPD Assessment Test (CAT) Score at Week 4
Time frame: Baseline (Day 1, pre-dose) and at Week 4
Number of Participants With Trelegy Related Non-serious Adverse Events (AEs)
Time frame: Up to 251 days
Number of Participants With Trelegy Related Serious Adverse Events (SAEs)
Time frame: Up to 251 days
Number of Participants With Trelegy Related AEs Leading to the Discontinuation
Time frame: Up to 251 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 40704458Ma J, Dou F, Zhou W, Li L, Zhu J, Zhang Y, Zhou L, Su L, Dong L, He Y, Ye A, Slade D, Zheng J. 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. Curr Med Res Opin. 2025 Jul;41(7):1363-1372. doi: 10.1080/03007995.2025.2536600. Epub 2025 Jul 29.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FF/UMEC/VI in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in COPD Assessment Test (CAT) Score at Week 12 (time frame: Baseline (Day 1, pre-dose) and at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05535972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.