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

NCT05535972 | Completed Phase 4 Results

• 1 other identifier: 217658
• Study Type: interventional
• Target: 463
• Locations: 1 country
• Sites: 1

Brief 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. TRELEGY and ELLIPTA are trademarks of the GlaxoSmithKline group of companies.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

TRELEGY ELLIPTA; Single Inhaler; Fluticasone Furoate; Umeclidinium Bromide; Vilanterol; FF/UMEC/VI

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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

  Baseline (Day 1, pre-dose) and at Week 12

• Percentage of Participants Having >=2 Unit Decrease in CAT Score From Baseline at Week 12

  Baseline (Day 1, pre-dose) and at Week 12

• Change From Baseline in COPD Assessment Test (CAT) Score at Week 4

  Baseline (Day 1, pre-dose) and at Week 4

Study Arms (1)

Participants receiving TRELEGY ELLIPTA

EXPERIMENTAL

Participants will receive FF/UMEC/VI, inhalation powder, once daily, in a single device (TRELEGY ELLIPTA) for 12 weeks.

Drug: FF/UMEC/VI

Interventions

FF/UMEC/VI DRUG

FF/UMEC/VI will be administered in a single inhaler Trelegy Ellipta.

Also known as: TRELEGY ELLIPTA

Participants receiving TRELEGY ELLIPTA

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Dongguan, 523326, China

Location

Related Publications (1)

• 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.

  PMID: 40704458 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: October 14, 2022
• Primary Completion: September 25, 2023
• Study Completion: September 25, 2023
• Last Updated: December 11, 2025
• Results First Posted: November 4, 2024

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

CN (1)