Efficacy and Safety of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in Chinese Participants With Inadequately Controlled Asthma

NCT04937387 | Completed Phase 3 Results

• 1 other identifier: 214263
• Study Type: interventional
• Target: 359
• Locations: 1 country
• Sites: 61

Brief Summary

The study aims to evaluate the efficacy, safety and tolerability of FF/UMEC/VI compared with FF/VI via ELLIPTA® inhaler in Chinese participants with inadequately controlled asthma. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.

Conditions

Asthma

Keywords

Asthma; Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI); Fluticasone Furoate/Vilanterol (FF/VI); ELLIPTA; Chinese

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (100ug FF)

  FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the highest FEV1 value obtained prior to the morning dose of investigational product. Baseline value is the latest acceptable assessment with non-missing value at the randomization visit (Visit 2).

  Baseline (pre-dose at Day 1) and Week 12

Secondary Outcomes (2)

• Change From Baseline in Trough FEV1 at Week 12 (200ug FF)

  Baseline (pre-dose at Day 1) and Week 12

• Change From Baseline in Asthma Control Questionnaire (ACQ-7) Total Score at Week 12

  Baseline (pre-dose at Day 1) and Week 12

Study Arms (4)

Cohort 1: Participants receiving FF/VI at Dose level 1 via ELLIPTA inhaler

EXPERIMENTAL

Drug: FF/VI; Device: ELLIPTA

Cohort 2: Participants receiving FF/UMEC/VI at Dose level 2 via ELLIPTA inhaler

EXPERIMENTAL

Drug: FF/UMEC/VI; Device: ELLIPTA

Cohort 3: Participants receiving FF/ VI at Dose level 3 via ELLIPTA inhaler

EXPERIMENTAL

Drug: FF/VI; Device: ELLIPTA

Cohort 4: Participants receiving FF/UMEC/VI at Dose level 4 via ELLIPTA inhaler

EXPERIMENTAL

Drug: FF/UMEC/VI; Device: ELLIPTA

Interventions

FF/VI DRUG

FF/VI will be administered.

Cohort 1: Participants receiving FF/VI at Dose level 1 via ELLIPTA inhaler; Cohort 3: Participants receiving FF/ VI at Dose level 3 via ELLIPTA inhaler

FF/UMEC/VI DRUG

FF/UMEC/VI will be administered.

Cohort 2: Participants receiving FF/UMEC/VI at Dose level 2 via ELLIPTA inhaler; Cohort 4: Participants receiving FF/UMEC/VI at Dose level 4 via ELLIPTA inhaler

ELLIPTA DEVICE

FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler.

Cohort 1: Participants receiving FF/VI at Dose level 1 via ELLIPTA inhaler; Cohort 2: Participants receiving FF/UMEC/VI at Dose level 2 via ELLIPTA inhaler; Cohort 3: Participants receiving FF/ VI at Dose level 3 via ELLIPTA inhaler; Cohort 4: Participants receiving FF/UMEC/VI at Dose level 4 via ELLIPTA inhaler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 18 years or older at the time of signing the informed consent.
• Documented history asthma diagnosis as defined by the Global Initiative for Asthma (GINA) at least one year prior to Visit 0.
• Participants with inadequately controlled asthma (ACQ-6 score \>=1.5) despite Inhaled Corticosteroids/Long-Acting Beta-2-Agonists (ICS/LABA) maintenance therapy at Visit 1.
• Participants who require daily ICS/LABA for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total dose of ICS of greater than \[\>\]250 micrograms (mcg) per day fluticasone propionate \[FP, or equivalent\]).
• A best pre-bronchodilator morning (AM) FEV1 \>=30 percent (%) and less than (\<) 85% of the predicted normal value at Visit 1. Predicted values will be based upon the European Respiratory Society (ERS) Global Lung Function Initiative.
• Airway reversibility defined as \>=12% and \>=200 milliliters (mL) increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1.
• All participants must be able to replace their current Short-Acting Beta-2-Agonists (SABA) inhaler with albuterol/salbutamol aerosol inhaler at Visit 1 as needed for the duration of the study. Participants must be judged capable of withholding albuterol/salbutamol for at least 6 hours prior to study visits.
• Male or female participants following contraceptive/barrier requirements and it should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of non-childbearing potential (WONCBP) or a woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the study.
• 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.

You may not qualify if:

• Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
• Any asthma exacerbation requiring a change in maintenance asthma therapy in the 6 weeks prior to Visit 1.
• Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, including all of the following:
• History of exposure to risk factors (especially tobacco smoke, occupational dusts and chemicals, smoke from home cooking and heating fuels).
• A post-albuterol/salbutamol FEV1/Forced Vital Capacity (FVC) ratio of \<0.70 and a post-albuterol/salbutamol FEV1 of less than or equal to (\<=)70% of predicted normal values.
• Onset of disease \>=40 years of age.
• Participants with current evidence of pneumonia, active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases or abnormalities other than asthma.
• Immune suppression (e.g., Human Immunodeficiency virus \[HIV\], Lupus) or other risk factors for pneumonia (e.g., neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis). Participants at potentially high risk (e.g., very low Body Mass Index \[BMI\], severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator.
• 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. 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.
• Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• Clinically significant Electrocardiogram (ECG) abnormality: Evidence of a clinically significant abnormality in the 12-lead ECG performed during screening. The Investigator will determine the clinical significance of each abnormal ECG finding in relation to the participant's medical history and exclude participants who would be at undue risk by participating in the trial. An abnormal and clinically significant finding is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following:
• Atrial Fibrillation with rapid ventricular rate \>120 beats per minute (bpm).
• Sustained or non-sustained ventricular tachycardia.
• Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted).
• QT interval corrected for heart rate by Fridericia's formula (QTcF) \>=500 milliseconds (msec) in participants with QRS \<120 msec and QTcF \>=530 msec in participants with QRS \>=120 msec.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (61)

GSK Investigational Site

Beijing, 100020, China

Location

GSK Investigational Site

Changchun, 130021, China

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GSK Investigational Site

Changsha, 410013, China

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GSK Investigational Site

Chengdu, 610041, China

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GSK Investigational Site

Chongqing, 400038, China

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GSK Investigational Site

Chongqing, China

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GSK Investigational Site

Dongguan, 523059, China

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GSK Investigational Site

Fuzhou, 350005, China

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GSK Investigational Site

Guangzhou, 510120, China

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GSK Investigational Site

Guangzhou, 510150, China

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GSK Investigational Site

Guangzhou, 510180, China

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GSK Investigational Site

Guangzhou, 510280, China

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GSK Investigational Site

Guilin, 541001, China

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GSK Investigational Site

Guilin, 541002, China

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GSK Investigational Site

Hangzhou, 310005, China

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GSK Investigational Site

Hangzhou, 310006, China

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GSK Investigational Site

Hefei, 230001, China

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GSK Investigational Site

Hohhot, 010017, China

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GSK Investigational Site

Hohhot, 010050, China

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GSK Investigational Site

Huizhou, 516000, China

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GSK Investigational Site

Jiangmen, 529030, China

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GSK Investigational Site

Jinan, 250012, China

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GSK Investigational Site

Kunming, 650051, China

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GSK Investigational Site

Lanzhou, 730020, China

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GSK Investigational Site

Lianyungang, 222006, China

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GSK Investigational Site

Nanchang, 330038, China

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GSK Investigational Site

Nanjing, 210006, China

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GSK Investigational Site

Nanning, 530022, China

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GSK Investigational Site

Qingdao, 266071, China

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GSK Investigational Site

Qingyuan, 510030, China

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GSK Investigational Site

Qinhuangdao, 66000, China

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GSK Investigational Site

Sanya, 570311, China

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GSK Investigational Site

Sanya, China

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GSK Investigational Site

Shanghai, 200032, China

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GSK Investigational Site

Shanghai, 200040, China

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GSK Investigational Site

Shanghai, 200090, China

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GSK Investigational Site

Shanghai, 200233, China

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GSK Investigational Site

Shanghai, 200433, China

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GSK Investigational Site

Shenyang, 110000, China

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GSK Investigational Site

Shenyang, 110004, China

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GSK Investigational Site

Shenzhen, 518020, China

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GSK Investigational Site

Shenzhen, 518036, China

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GSK Investigational Site

Shenzhen, 518053, China

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GSK Investigational Site

Shijiazhuang, 050000, China

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GSK Investigational Site

Taiyuan, 30000, China

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GSK Investigational Site

Tianjin, 300052, China

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GSK Investigational Site

Ürümqi, 830054, China

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GSK Investigational Site

Wenzhou, 323027, China

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GSK Investigational Site

Wuhan, 430060, China

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GSK Investigational Site

Wuhan, 430061, China

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GSK Investigational Site

Wuxi, 214023, China

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GSK Investigational Site

Xi'an, 710000, China

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GSK Investigational Site

Xiamen, 361004, China

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GSK Investigational Site

Xinxiang, 453004, China

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GSK Investigational Site

Xuzhou, 221006, China

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GSK Investigational Site

Yinchuan, 750004, China

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GSK Investigational Site

Zhanjiang, 524001, China

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GSK Investigational Site

Zhanjiang, 524045, China

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GSK Investigational Site

Zhengzhou, 450000, China

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GSK Investigational Site

Zhongshan, 528400, China

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GSK Investigational Site

Zunyi, 563114, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 24, 2021
• Study Start: July 29, 2021
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: August 11, 2025
• Results First Posted: August 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

CN (61)