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CompletedNCT04923347Updated Mar 24, 2025Results posted

A Study to Evaluate the Safety and Efficacy of Fluticasone Furoate (FF)/Umeclidinium(UMEC)/Vilanterol (VI) in Participants With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 4 interventional study of FF/UMEC/VI and ELLIPTA in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 14 sites in India. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-03-24.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
229
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study summary

This study will evaluate safety and efficacy of FF/UMEC/VI via ELLIPTA® inhaler. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive

Keywords

  • Chronic Obstructive Pulmonary Disease
  • ELLIPTA
  • Fluticasone Furoate
  • Umeclidinium
  • Vilanterol
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 229 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • A signed and dated written informed consent prior to study participation
  • Participants 40 years of age or older at Screening (Visit 1)
  • Male and female participants will be included in the study. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and until the safety follow-up contact after the last dose of study intervention.
  • An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society.
  • Current or former cigarette smokers with a history of cigarette smoking of greater than equal to (>=)10 pack-years at Screening (Visit 1) (number of pack years = [number of cigarettes per day divided by 20] times number of years smoked [for example 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
  • Participant with history of >=2 moderate exacerbations or one severe (hospitalized) exacerbation in the previous 12 months, and with a score of >=10 on the COPD Assessment Test (CAT) eligible for the study treatment in the opinion of the investigator and documented post salbutamol FEV1/ Forced Vital Capacity (FVC) ratio of \<0.70
  • Participant must be receiving daily long-acting maintenance treatment for their COPD for at least 3 months prior to Screening. To be eligible for the study treatment phase, participants must be compliant with their existing COPD maintenance therapy (in the opinion of the investigator) for the preceding two weeks prior to screening.
  • A negative test for active Coronavirus Disease 2019 (COVID-19) at Visit 1. The test should be done using a molecular (Polymerase chain reaction [PCR] or antigen test) approved by the country regulatory authorities.

Exclusion criteria

Exclusion Criteria:

  • Women who are pregnant or lactating or are planning on becoming pregnant during the study.
  • Participants with a current diagnosis of asthma. (Participants with a prior history of asthma are eligible if they have a current diagnosis of COPD).
  • Documented (medical records) evidence of reversibility. Reversibility is defined as an increase in FEV1 of >=12 percent (%) and >=200 milliliter (mL) following administration of salbutamol. Participants defined as non-reversible will have a post-salbutamol increase in FEV1 of \<200mL or a >=200mL increase that is \<12% from pre-salbutamol baselineParticipants with alpha 1-antitrypsin deficiency as the underlying cause of COPD.
  • Participants with active tuberculosis, lung cancer, and clinically significant (in the opinion of the investigator): bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
  • Participants with lung volume reduction surgery within the 12 months prior to Screening
  • Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids and/or antibiotics (if applicable). In addition, any participant that experiences pneumonia and/or moderate or severe COPD exacerbation within the preceding two weeks prior to screening will be excluded.
  • Respiratory tract infection that has not resolved at least 7 days prior to Screening.
  • Participants with known COVID-19 positive contacts within the past 14 days should be excluded for at least 14 days since the exposure and the participant remains symptom free. Participants with symptoms suggestive of active COVID-19 infection e.g. fever, cough (new or worsened), etc. are also excluded.
  • Chest x-ray (poster anterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on chest x-ray (CXR) (e.g. significant cardiomegaly, pleural effusion or scarring).
  • Participants with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled.
  • Abnormal and clinically significant 12-lead electrocardiogram (ECG) finding at Visit 1.
  • Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3 Liters per minute (L/min) at screening (Oxygen use \<=3L/min flow at rest is not exclusionary.)
  • Participants must not start the acute phase of a pulmonary rehabilitation program within the 4 weeks prior to Visit 1.
  • Participants who are medically unable to withhold their salbutamol for the 4-hour period required prior to spirometry testing at each study visit.
  • In the opinion of the investigator, any participant who is unable to read and/or would not be able to complete study related materials.
  • Use of the following medications within the following time intervals prior to Visit 1 or during the study:
  • Participants receiving antibiotics for long term therapy are not eligible for the study.
  • No use of systemic, Oral, parenteral corticosteroids within 30 days prior to screening (Intra-articular injections are allowed).
  • No use of any other investigational drug within 30 days or 5 half-lives whichever is longer prior to screening.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
229 participants (actual)

Study arms

  • Experimental
    Participants receiving FF/UMEC/VI via ELLIPTA inhaler

    Drug: FF/UMEC/VI · Device: ELLIPTA

Interventions

  • DrugFF/UMEC/VI

    FF/UMEC/VI will be administered

  • DeviceELLIPTA

    Participants will receive FF/UMEC/VI using ELLIPTA inhaler.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESIs)

    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. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other important medical event according to medical or scientific judgement. Protocol defined AESIs were included. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

    Time frame: Up to approximately 40 weeks

Secondary outcomes

  1. Change From Baseline (CFB) in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 28 and Day 85

    FEV1 is a measure of lung function defined as the maximal amount of air that can be forcefully exhaled in one second. It was measured using spirometry. Baseline is defined as the last non-missing observation made prior to the first administration of study treatment including those from unscheduled visits. Trough FEV1 on Day 28 was defined as the mean of the FEV1 values obtained prior to dosing on Day 28. Trough FEV1 on Day 85 was defined as the mean of the FEV1 values obtained 24 hours after morning dosing on Day 84.

    Time frame: Baseline (Day 1), Day 28 and Day 85

07

Results

Posted Mar 24, 2025

Participant flow

Participant flow — Overall Study
MilestoneFF/UMEC/VI ELLIPTA
Started229
Completed215
Not completed14
Withdrew: Withdrawal by subject14

Outcome measures

PrimaryNumber of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESIs)

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. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other important medical event according to medical or scientific judgement. Protocol defined AESIs were included. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

Time frame:
Up to approximately 40 weeks
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESIs)
ParticipantsFF/UMEC/VI ELLIPTA
AEs35
SAEs1
AESIs0
SecondaryChange From Baseline (CFB) in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 28 and Day 85

FEV1 is a measure of lung function defined as the maximal amount of air that can be forcefully exhaled in one second. It was measured using spirometry. Baseline is defined as the last non-missing observation made prior to the first administration of study treatment including those from unscheduled visits. Trough FEV1 on Day 28 was defined as the mean of the FEV1 values obtained prior to dosing on Day 28. Trough FEV1 on Day 85 was defined as the mean of the FEV1 values obtained 24 hours after morning dosing on Day 84.

Time frame:
Baseline (Day 1), Day 28 and Day 85
Reported as:
Mean · Liters
Change From Baseline (CFB) in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 28 and Day 85
LitersFF/UMEC/VI ELLIPTA
Baseline1.3645 ± 0.58677
CFB to Day 280.0542 ± 0.21577
CFB to Day 850.0317 ± 0.25852

Adverse events

Collected over All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 40 weeks.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
FF/UMEC/VI ELLIPTA0/229 (0%)1/229 (0.4%)19/229 (8.3%)
Most frequent serious events
Most frequent serious events
EventFF/UMEC/VI ELLIPTA
DyspnoeaRespiratory, thoracic and mediastinal disorders1/229
Most frequent other events
Most frequent other events
EventFF/UMEC/VI ELLIPTA
PyrexiaGeneral disorders10/229
HeadacheNervous system disorders9/229

Baseline characteristics

Age, Continuous
Age, Continuous(YEARS)FF/UMEC/VI ELLIPTA
Mean60.4 ± 10.09
Sex: Female, Male
Sex: Female, Male(Participants)FF/UMEC/VI ELLIPTA
Female9
Male220
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)FF/UMEC/VI ELLIPTA
Asian229
08

Study locations

14 sites
  • GSK Investigational Site
    Ajmer, 305001, India
  • GSK Investigational Site
    Bangalore, 560092, India
  • GSK Investigational Site
    Bikaner, 334001, India
  • GSK Investigational Site
    Hyderabad, 500084, India
  • GSK Investigational Site
    Jaipur, 302039, India
  • GSK Investigational Site
    Kolkata, 700014, India
  • GSK Investigational Site
    Kolkata, 700027, India
  • GSK Investigational Site
    Kozhikode, 673008, India
  • GSK Investigational Site
    Mumbai, 401107, India
  • GSK Investigational Site
    Mysore, 57001, India
  • GSK Investigational Site
    Nagpur, 44009, India
  • GSK Investigational Site
    Nashik, 422007, India
  • GSK Investigational Site
    Pondy-Cuddalore ECR Main Road Pillaiyarkuppam Pond, 605402, India
  • GSK Investigational Site
    Pune, 411047, India
09

References and documents

Study documents

  • Study protocol · May 3, 2023
  • Statistical analysis plan · Apr 25, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04923347
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jun 11, 2021
Start date
Jun 6, 2023
Primary completion
Mar 14, 2024
Completion
Mar 14, 2024
Results posted
Mar 24, 2025
Last update
Mar 24, 2025

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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