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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05535972
• Other study ID #: 217658
• Status: Completed
• Phase: Phase 4
• Start date: October 14, 2022
• Est. completion date: September 25, 2023

Study information

• Verified date: March 2024
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: September 25, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Chengdu
China	GSK Investigational Site	Dongguan	Guangdong
China	GSK Investigational Site	Fuzhou
China	GSK Investigational Site	Guangzhou
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Hangzhou	Zhejiang
China	GSK Investigational Site	Hangzhou
China	GSK Investigational Site	Hefei
China	GSK Investigational Site	Huizhou	Guangdong
China	GSK Investigational Site	Huizhou	Guangdong
China	GSK Investigational Site	Jinjiang	Fujian
China	GSK Investigational Site	Lanzhou
China	GSK Investigational Site	Mianyang
China	GSK Investigational Site	Nanchang
China	GSK Investigational Site	Nanchang	Jiangxi
China	GSK Investigational Site	Panzhihua
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shenyang
China	GSK Investigational Site	Shenyang
China	GSK Investigational Site	Shenzhen
China	GSK Investigational Site	Taizhou
China	GSK Investigational Site	Tianjin
China	GSK Investigational Site	Weifang
China	GSK Investigational Site	Wuhan
China	GSK Investigational Site	Xianyang
China	GSK Investigational Site	Yinchuan	Ningxia
China	GSK Investigational Site	Yiwu

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in COPD Assessment Test (CAT) score	CAT is a validated 8-item questionnaire developed for use in routine clinical practice to measure the health status of patients with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicated greater disease impact.	Baseline (Day 1) and at Week 12
Secondary	Change from baseline of Modified Medical Research Council (mMRC) Score	The mMRC will be used to assess the breathlessness state of the patient before and after the treatment. Participants will be scored on a scale of 0-4 depending on their disability due to shortness of breath from 0 (no impact) to 4 (worst possible impact). Higher scores indicated greater disease impact.	Baseline (Day 1) and at Week 12
Secondary	Change from baseline in Pre-dose Forced Expiratory Volume in 1 second (FEV1)	FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.	Baseline (Day 1) and at Week 12
Secondary	Percentage of participants having = 2 unit decrease in CAT score from baseline at week 12.	CAT is a validated 8-item questionnaire developed for use in routine clinical practice to measure the health status of patients with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicated greater disease impact. A change of 2 unit compared to baseline is considered as the minimum clinical meaningful difference.	Baseline (Day 1) and at Week 12
Secondary	Number of participants with Trelegy related Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.	Up to Week 12
Secondary	Number of participants with Serious Adverse Events (SAEs)	SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician.	Up to Week 12
Secondary	Number of participants with AEs that lead to the discontinuation of Trelegy Ellipta		Up to week 12