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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05535972

Collaborator

(none)

460

Enrollment

Arm

12.8

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: FF/UMEC/VI	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

460 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 18, 2022

Anticipated Primary Completion Date :

Oct 13, 2023

Anticipated Study Completion Date :

Oct 13, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants receiving TRELEGY ELLIPTA Participants will receive FF/UMEC/VI, inhalation powder, once daily, in a single device (TRELEGY ELLIPTA) for 12 weeks.	Drug: FF/UMEC/VI FF/UMEC/VI will be administered in a single inhaler Trelegy Ellipta. Other Names: TRELEGY ELLIPTA

Arm

Intervention/Treatment

Experimental: Participants receiving TRELEGY ELLIPTA

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

Drug: FF/UMEC/VI

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

Other Names:

TRELEGY ELLIPTA

Outcome Measures

Primary Outcome Measures

Change from baseline in COPD Assessment Test (CAT) score [Baseline (Day 1) and 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.

Secondary Outcome Measures

Change from baseline of Modified Medical Research Council (mMRC) Score [Baseline (Day 1) and at Week 12]
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.
Change from baseline in Pre-dose Forced Expiratory Volume in 1 second (FEV1) [Baseline (Day 1) and 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.
Percentage of participants having ≥ 2 unit decrease in CAT score from baseline at week 12. [Baseline (Day 1) and 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.
Number of participants with Trelegy related Adverse Events (AEs) [Up to Week 12]
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.
Number of participants with Serious Adverse Events (SAEs) [Up to Week 12]
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.
Number of participants with AEs that lead to the discontinuation of Trelegy Ellipta [Up to week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.