Pulmonary Disease, Chronic ObstructivePhase 4NCT04923347

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 study testing FF/UMEC/VI and ELLIPTA in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 14 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: FF/UMEC/VI and ELLIPTA
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 229 participants
Where: 14 sitesIndia
Study dates: 6 Jun 2023to 14 Mar 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 19Show fewer

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.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

India14 sites

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

Other trials in India

About this study

Official title: Phase IV, 12-week, Single Arm, Open Label Study Evaluating the Safety and Efficacy of Fixed Dose Triple Combination FF/UMEC/VI Administered Once Daily in the Morning Via a Dry Powder Inhaler in Participants With Chronic Obstructive Pulmonary Disease in India

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

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: FF/UMEC/VI, ELLIPTA
Keywords: Chronic Obstructive Pulmonary Disease, ELLIPTA, Fluticasone Furoate, Umeclidinium, Vilanterol
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FF/UMEC/VIDrug
FF/UMEC/VI will be administered
ELLIPTADevice
Participants will receive FF/UMEC/VI using ELLIPTA inhaler.

Study groups in NCT04923347
Study group	Role	What they receive
Participants receiving FF/UMEC/VI via ELLIPTA inhaler	Experimental	Not described Receives: Drug: FF/UMEC/VI; Device: ELLIPTA

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: Baseline (Day 1), Day 28 and Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 202314 Mar 2024

First posted11 Jun 2021
Study start6 Jun 2023
Primary completion14 Mar 2024
Study completion14 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Participants will receive FF/UMEC/VI via ELLIPTA inhaler.
Masking: None (open label)
Enrolment: 229 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04923347
Sponsor's protocol ID: 212655
Status last verified: Mar 2025
First submitted: 6 Jun 2021
Last updated: 24 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IV, 12-week, Single Arm, Open Label Study Evaluating the Safety and Efficacy of Fixed Dose Triple Combination FF/UMEC/VI Administered Once Daily in the Morning Via a Dry Powder Inhaler in Participants With Chronic Obstructive Pulmonary Disease in India
ClinicalTrials.gov ID: NCT04923347
Acronym / sponsor ID: 212655
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease, ELLIPTA, Fluticasone Furoate, Umeclidinium, Vilanterol
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 229 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 6 Jun 2023 (actual)
Primary completion: 14 Mar 2024 (actual)
Study completion: 14 Mar 2024 (actual)
First posted: 11 Jun 2021 (actual)
Results: Posted 24 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Participants will receive FF/UMEC/VI via ELLIPTA inhaler.

Arm	Type	Receives
Participants receiving FF/UMEC/VI via ELLIPTA inhaler	Experimental	Drug: FF/UMEC/VI, Device: ELLIPTA

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FF/UMEC/VIFF/UMEC/VI will be administered	Drug	Participants receiving FF/UMEC/VI via ELLIPTA inhaler
ELLIPTAParticipants will receive FF/UMEC/VI using ELLIPTA inhaler.	Device	Participants receiving FF/UMEC/VI via ELLIPTA inhaler

Primary outcome

Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESIs)
Time frame: Up to approximately 40 weeks
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).

1 secondary outcome

Change From Baseline (CFB) in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 28 and Day 85
Time frame: Baseline (Day 1), Day 28 and Day 85

Results and safety

Results posted to the registry on 24 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FF/UMEC/VI ELLIPTA	229	215

Primary outcome: Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESIs)

Time frame: Up to approximately 40 weeks. Count of participants. Unit: Participants

Measure	FF/UMEC/VI ELLIPTA n = 229
AEs	35
SAEs	1
AESIs	0

Population analysed: Intent-to-Treat (ITT) population included participants who received at least one dose of study treatment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 40 weeks.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FF/UMEC/VI ELLIPTA	1 of 229 (0.4%)	19 of 229 (8.3%)	0 of 229

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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/

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Active, not recruiting
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FF/UMEC/VI and ELLIPTA in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 14 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESIs) (time frame: Up to approximately 40 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04923347.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.