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AsthmaPhase 3NCT04937387

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

A Phase 3 study testing FF/VI, FF/UMEC/VI and ELLIPTA in people with Asthma, run by GlaxoSmithKline at 61 sites in China.

Completed

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
FF/VI, FF/UMEC/VI and ELLIPTA
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
359 participants
Where
61 sitesChina
Study dates
29 Jul 2021to 5 Aug 2024
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Participants with inadequately controlled asthma (ACQ-6 score >=1.5) at Visit 2.
  • A best pre-bronchodilator morning (AM) FEV1 >=30% and <90% of the predicted normal value at Visit 2. Predicted values will be based upon the ERS Global Lung Function Initiative (Quanjer).
  • Liver function tests at Visit 1:
  • Alanine aminotransferase (ALT) <2 times upper limit of normal (ULN).
  • Alkaline phosphatase <=1.5 times ULN.
  • Bilirubin <=1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • Compliance with completion of the Electronic diary reporting defined as completion of all questions/assessment on >=4 of the last 7 days during the run-in period.

Who cannot join

  • 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.
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  • 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.
  • Participants with any of the following at Screening (Visit 1):
  • Myocardial infarction or unstable angina in the last 6 months.
  • Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 3 months.
  • New York Heart Association (NYHA) Class IV Heart failure [American Heart Association, 2016].
  • Participants with a medical condition such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy or bladder neck obstruction should only be included if in the opinion of the Investigator the benefit outweighs the risk and that the condition would not contraindicate study participation.
  • Participants with carcinoma that has not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.
  • Participants with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
  • Participants who are medically unable to withhold their albuterol/salbutamol for the 6-hour period required prior to spirometry testing at each study visit.
  • Participants who are:
  • Current smokers (defined as participants who have used inhaled tobacco products within the 12 months prior to Visit 1, e.g. cigarettes, electronic-cigarettes/vaping, cigars or pipe tobacco).
  • Former smokers with a smoking history of >=10 pack years (e.g. >=20 cigarettes per day for 10 years).
  • Participants with a known or suspected history of alcohol or drug abuse within the last 2 years.
  • A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate.
  • Participants at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
  • Study Investigators, sub-Investigators, study coordinators, employees of a participating Investigator or study site, or immediate family members of the aforementioned that is involved with this study.
  • In the opinion of the Investigator, any participant who is unable to read and/or would not be able to complete study related materials.
  • Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the participant's asthma status or the participant's ability to participate in the study.
  • Evidence of a severe exacerbation during screening or the run-in period, defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
  • Changes in asthma medication (excluding run-in medication and albuterol/salbutamol inhalation aerosol provided at Visit 1).
  • Evidence of clinically significant abnormal laboratory tests during screening or run-in which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each Investigator will use his/her own discretion in determining the clinical significance of the abnormality.

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

China61 sites

  • GSK Investigational Site

    Beijing, 100020

  • GSK Investigational Site

    Changchun, 130021

  • GSK Investigational Site

    Changsha, 410013

  • GSK Investigational Site

    Chengdu, 610041

  • GSK Investigational Site

    Chongqing, 400038

  • GSK Investigational Site

    Chongqing

  • GSK Investigational Site

    Dongguan, 523059

  • GSK Investigational Site

    Fuzhou, 350005

  • GSK Investigational Site

    Guangzhou, 510120

  • GSK Investigational Site

    Guangzhou, 510150

  • GSK Investigational Site

    Guangzhou, 510180

  • GSK Investigational Site

    Guangzhou, 510280

  • GSK Investigational Site

    Guilin, 541001

  • GSK Investigational Site

    Guilin, 541002

  • GSK Investigational Site

    Hangzhou, 310005

  • GSK Investigational Site

    Hangzhou, 310006

  • GSK Investigational Site

    Hefei, 230001

  • GSK Investigational Site

    Hohhot, 010017

  • GSK Investigational Site

    Hohhot, 010050

  • GSK Investigational Site

    Huizhou, 516000

  • GSK Investigational Site

    Jiangmen, 529030

  • GSK Investigational Site

    Jinan, 250012

  • GSK Investigational Site

    Kunming, 650051

  • GSK Investigational Site

    Lanzhou, 730020

  • GSK Investigational Site

    Lianyungang, 222006

  • GSK Investigational Site

    Nanchang, 330038

  • GSK Investigational Site

    Nanjing, 210006

  • GSK Investigational Site

    Nanning, 530022

  • GSK Investigational Site

    Qingdao, 266071

  • GSK Investigational Site

    Qingyuan, 510030

  • GSK Investigational Site

    Qinhuangdao, 66000

  • GSK Investigational Site

    Sanya, 570311

  • GSK Investigational Site

    Sanya

  • GSK Investigational Site

    Shanghai, 200032

  • GSK Investigational Site

    Shanghai, 200040

  • GSK Investigational Site

    Shanghai, 200090

  • GSK Investigational Site

    Shanghai, 200233

  • GSK Investigational Site

    Shanghai, 200433

  • GSK Investigational Site

    Shenyang, 110000

  • GSK Investigational Site

    Shenyang, 110004

  • GSK Investigational Site

    Shenzhen, 518020

  • GSK Investigational Site

    Shenzhen, 518036

  • GSK Investigational Site

    Shenzhen, 518053

  • GSK Investigational Site

    Shijiazhuang, 050000

  • GSK Investigational Site

    Taiyuan, 30000

  • GSK Investigational Site

    Tianjin, 300052

  • GSK Investigational Site

    Ürümqi, 830054

  • GSK Investigational Site

    Wenzhou, 323027

  • GSK Investigational Site

    Wuhan, 430060

  • GSK Investigational Site

    Wuhan, 430061

  • GSK Investigational Site

    Wuxi, 214023

  • GSK Investigational Site

    Xi'an, 710000

  • GSK Investigational Site

    Xiamen, 361004

  • GSK Investigational Site

    Xinxiang, 453004

  • GSK Investigational Site

    Xuzhou, 221006

  • GSK Investigational Site

    Yinchuan, 750004

  • GSK Investigational Site

    Zhanjiang, 524001

  • GSK Investigational Site

    Zhanjiang, 524045

  • GSK Investigational Site

    Zhengzhou, 450000

  • GSK Investigational Site

    Zhongshan, 528400

  • GSK Investigational Site

    Zunyi, 563114

Other trials in China

About this study

Official title: A Phase III, 12 Week, Randomized, Double-blind, 4 Arm Parallel Group Bridging Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination FF/UMEC/VI Once-daily Via a Dry Powder Inhaler With Dual Combination of FF/VI, Administered in Chinese Participants With Inadequately Controlled Asthma

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
Being tested
FF/VI, FF/UMEC/VI, ELLIPTA
Keywords
Asthma, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI), Fluticasone Furoate/Vilanterol (FF/VI), ELLIPTA, Chinese
Medical subject headings
Asthma

What participants receive

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

  • FF/VIDrug

    FF/VI will be administered.

  • FF/UMEC/VIDrug

    FF/UMEC/VI will be administered.

  • ELLIPTADevice

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

Study groups in NCT04937387
Study groupRoleWhat they receive
Cohort 1: Participants receiving FF/VI at Dose level 1 via ELLIPTA inhalerExperimentalNot described
Receives: Drug: FF/VI; Device: ELLIPTA
Cohort 2: Participants receiving FF/UMEC/VI at Dose level 2 via ELLIPTA inhalerExperimentalNot described
Receives: Drug: FF/UMEC/VI; Device: ELLIPTA
Cohort 3: Participants receiving FF/ VI at Dose level 3 via ELLIPTA inhalerExperimentalNot described
Receives: Drug: FF/VI; Device: ELLIPTA
Cohort 4: Participants receiving FF/UMEC/VI at Dose level 4 via ELLIPTA inhalerExperimentalNot 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.

  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).

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

Secondary outcomes (2)

  1. Change From Baseline in Trough FEV1 at Week 12 (200ug 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)

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

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

    ACQ-7 is a 7-item questionnaire to assess asthma control in participants. Six attributes are measured with a patient-completed questionnaire, and the questions are designed to be self-completed by the participant. The six patient-reported questions enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions consist of a zero (no impairment/limitation) to six (total impairment/ limitation) scale. The recall period is the past week. The seventh attribute of the ACQ-7 is lung function (FEV1%-predicted) which was assessed via study visit spirometry. All 7 items of ACQ have response on 0-6 ordinal scale (0=no impairment/limitation, 6=total impairment/limitation). The total score is calculated as the average of all non-missing item responses, ranges from 0 to 6. Higher score indicates worst symptoms.

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

Timeline

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

  1. First posted24 Jun 2021
  2. Study start29 Jul 2021
  3. Primary completion5 Aug 2024
  4. Study completion5 Aug 2024

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
359 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04937387
Sponsor's protocol ID
214263
Status last verified
Jul 2025
First submitted
2 Jun 2021
Last updated
11 Aug 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FF/VI, FF/UMEC/VI and ELLIPTA in people with Asthma, run by GlaxoSmithKline at 61 sites in China.

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 16 inclusion and 35 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 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 11 Aug 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?

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (100ug FF) (time frame: Baseline (pre-dose at Day 1) and Week 12). 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 NCT04937387.

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 11 Aug 2025.

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