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
This study will evaluate safety and efficacy of FF/UMEC/VI via ELLIPTA® inhaler. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.
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 →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.
Exclusion Criteria:
Drug: FF/UMEC/VI · Device: ELLIPTA
FF/UMEC/VI will be administered
Participants will receive FF/UMEC/VI using ELLIPTA inhaler.
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
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
| Milestone | FF/UMEC/VI ELLIPTA |
|---|---|
| Started | 229 |
| Completed | 215 |
| Not completed | 14 |
| Withdrew: Withdrawal by subject | 14 |
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).
| Participants | FF/UMEC/VI ELLIPTA |
|---|---|
| AEs | 35 |
| SAEs | 1 |
| AESIs | 0 |
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.
| Liters | FF/UMEC/VI ELLIPTA |
|---|---|
| Baseline | 1.3645 ± 0.58677 |
| CFB to Day 28 | 0.0542 ± 0.21577 |
| CFB to Day 85 | 0.0317 ± 0.25852 |
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FF/UMEC/VI ELLIPTA | 0/229 (0%) | 1/229 (0.4%) | 19/229 (8.3%) |
| Event | FF/UMEC/VI ELLIPTA |
|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/229 |
| Event | FF/UMEC/VI ELLIPTA |
|---|---|
| PyrexiaGeneral disorders | 10/229 |
| HeadacheNervous system disorders | 9/229 |
| Age, Continuous(YEARS) | FF/UMEC/VI ELLIPTA |
|---|---|
| Mean | 60.4 ± 10.09 |
| Sex: Female, Male(Participants) | FF/UMEC/VI ELLIPTA |
|---|---|
| Female | 9 |
| Male | 220 |
| Race/Ethnicity, Customized(Participants) | FF/UMEC/VI ELLIPTA |
|---|---|
| Asian | 229 |
Documents are hosted by the registry — open the source record to download them.
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
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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