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

NCT ID: NCT05535972

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 463 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-14
• Study Completion Date: 2023-09-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants receiving TRELEGY ELLIPTA

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

Group Type: EXPERIMENTAL

FF/UMEC/VI

Intervention Type: DRUG

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

Interventions

FF/UMEC/VI

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

Intervention Type: DRUG

Other Intervention Names

TRELEGY ELLIPTA

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Dongguan, , China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 40704458 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

217658

Identifier Type: -

Identifier Source: org_study_id