Clinical trial NCT05535972: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: TRELEGY ELLIPTA
Single Inhaler
Fluticasone Furoate
Umeclidinium Bromide
Vilanterol
FF/UMEC/VI
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2022-09-10
Enrollment: 463
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in COPD Assessment Test (CAT) Score at Week 12
timeFrame: Baseline (Day 1, pre-dose) and at Week 12
Secondary outcomes:
measure: Change From Baseline in Modified Medical Research Council (mMRC) Grading System at Week 12 (Patient Version)
timeFrame: Baseline (Day 1, pre-dose) and at Week 12
measure: Change From Baseline in Modified Medical Research Council (mMRC) Dyspnea Scale at Week 12 (Physician Version)
timeFrame: Baseline (Day 1, pre-dose) and at Week 12
measure: Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) at Week 12
timeFrame: Baseline (Day 1, pre-dose) and at Week 12
measure: Percentage of Participants Having >=2 Unit Decrease in CAT Score From Baseline at Week 12
timeFrame: Baseline (Day 1, pre-dose) and at Week 12
measure: Change From Baseline in COPD Assessment Test (CAT) Score at Week 4
timeFrame: Baseline (Day 1, pre-dose) and at Week 4
measure: Number of Participants With Trelegy Related Non-serious Adverse Events (AEs)
timeFrame: Up to 251 days
measure: Number of Participants With Trelegy Related Serious Adverse Events (SAEs)
timeFrame: Up to 251 days
measure: Number of Participants With Trelegy Related AEs Leading to the Discontinuation
timeFrame: Up to 251 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: GSK Investigational Site
city: Chengdu
country: China
facility: GSK Investigational Site
city: Dongguan
country: China
facility: GSK Investigational Site
city: Fuzhou
country: China
facility: GSK Investigational Site
city: Gansu
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: Hangzhou
country: China
facility: GSK Investigational Site
city: Hangzhou
country: China
facility: GSK Investigational Site
city: Hefei
country: China
facility: GSK Investigational Site
city: Huizhou
country: China
facility: GSK Investigational Site
city: Huizhou
country: China
facility: GSK Investigational Site
city: Jiangxi
country: China
facility: GSK Investigational Site
city: Jinjiang
country: China
facility: GSK Investigational Site
city: Mianyang
country: China
facility: GSK Investigational Site
city: Nanchang
country: China
facility: GSK Investigational Site
city: Panzhihua
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shenyang
country: China
facility: GSK Investigational Site
city: Shenyang
country: China
facility: GSK Investigational Site
city: Shenzhen
country: China
facility: GSK Investigational Site
city: Shenzhen
country: China
facility: GSK Investigational Site
city: Taizhou
country: China
facility: GSK Investigational Site
city: Tianjin
country: China
facility: GSK Investigational Site
city: Weifang
country: China
facility: GSK Investigational Site
city: Wuhan
country: China
facility: GSK Investigational Site
city: Xianyang
country: China
facility: GSK Investigational Site
city: Yinchuan
country: China
facility: GSK Investigational Site
city: Yiwu
country: China
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: