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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Participants receiving FF/VI at Dose level 1 via ELLIPTA inhaler | Experimental |
| |
| Cohort 2: Participants receiving FF/UMEC/VI at Dose level 2 via ELLIPTA inhaler | Experimental |
| |
| Cohort 3: Participants receiving FF/ VI at Dose level 3 via ELLIPTA inhaler | Experimental |
| |
| Cohort 4: Participants receiving FF/UMEC/VI at Dose level 4 via ELLIPTA inhaler | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FF/VI | Drug | FF/VI will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion criteria:
Exclusion Criteria:
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:
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:
Participants with any of the following at Screening (Visit 1):
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:
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.
Inclusion criteria for randomization:
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:
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.
Exclusion criteria for randomization:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Beijing | 100020 | China | |||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
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 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.
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A total of 359 participants were randomized, however 1 participant was randomized in error and did not receive any study intervention. Therefore, 358 participants were included in 'Intent to Treat (ITT)' Population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluticasone Furoate [FF] 100 Microgram[ug] / Vilanterol [VI] 25 ug | Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate [FF] and 25 ug vilanterol [VI] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 18, 2022 | Jul 24, 2025 |
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| FF/UMEC/VI | Drug | FF/UMEC/VI will be administered. |
|
| ELLIPTA | Device | FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler. |
|
| Baseline (pre-dose at Day 1) and Week 12 |
| 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. | Baseline (pre-dose at Day 1) and Week 12 |
| Changchun |
| 130021 |
| China |
| GSK Investigational Site | Changsha | 410013 | China |
| GSK Investigational Site | Chengdu | 610041 | China |
| GSK Investigational Site | Chongqing | 400038 | China |
| GSK Investigational Site | Chongqing | China |
| GSK Investigational Site | Dongguan | 523059 | China |
| GSK Investigational Site | Fuzhou | 350005 | China |
| GSK Investigational Site | Guangzhou | 510120 | China |
| GSK Investigational Site | Guangzhou | 510150 | China |
| GSK Investigational Site | Guangzhou | 510180 | China |
| GSK Investigational Site | Guangzhou | 510280 | China |
| GSK Investigational Site | Guilin | 541001 | China |
| GSK Investigational Site | Guilin | 541002 | China |
| GSK Investigational Site | Hangzhou | 310005 | China |
| GSK Investigational Site | Hangzhou | 310006 | China |
| GSK Investigational Site | Hefei | 230001 | China |
| GSK Investigational Site | Hohhot | 010017 | China |
| GSK Investigational Site | Hohhot | 010050 | China |
| GSK Investigational Site | Huizhou | 516000 | China |
| GSK Investigational Site | Jiangmen | 529030 | China |
| GSK Investigational Site | Jinan | 250012 | China |
| GSK Investigational Site | Kunming | 650051 | China |
| GSK Investigational Site | Lanzhou | 730020 | China |
| GSK Investigational Site | Lianyungang | 222006 | China |
| GSK Investigational Site | Nanchang | 330038 | China |
| GSK Investigational Site | Nanjing | 210006 | China |
| GSK Investigational Site | Nanning | 530022 | China |
| GSK Investigational Site | Qingdao | 266071 | China |
| GSK Investigational Site | Qingyuan | 510030 | China |
| GSK Investigational Site | Qinhuangdao | 66000 | China |
| GSK Investigational Site | Sanya | 570311 | China |
| GSK Investigational Site | Sanya | China |
| GSK Investigational Site | Shanghai | 200032 | China |
| GSK Investigational Site | Shanghai | 200040 | China |
| GSK Investigational Site | Shanghai | 200090 | China |
| GSK Investigational Site | Shanghai | 200233 | China |
| GSK Investigational Site | Shanghai | 200433 | China |
| GSK Investigational Site | Shenyang | 110000 | China |
| GSK Investigational Site | Shenyang | 110004 | China |
| GSK Investigational Site | Shenzhen | 518020 | China |
| GSK Investigational Site | Shenzhen | 518036 | China |
| GSK Investigational Site | Shenzhen | 518053 | China |
| GSK Investigational Site | Shijiazhuang | 050000 | China |
| GSK Investigational Site | Taiyuan | 30000 | China |
| GSK Investigational Site | Tianjin | 300052 | China |
| GSK Investigational Site | Ürümqi | 830054 | China |
| GSK Investigational Site | Wenzhou | 323027 | China |
| GSK Investigational Site | Wuhan | 430060 | China |
| GSK Investigational Site | Wuhan | 430061 | China |
| GSK Investigational Site | Wuxi | 214023 | China |
| GSK Investigational Site | Xi'an | 710000 | China |
| GSK Investigational Site | Xiamen | 361004 | China |
| GSK Investigational Site | Xinxiang | 453004 | China |
| GSK Investigational Site | Xuzhou | 221006 | China |
| GSK Investigational Site | Yinchuan | 750004 | China |
| GSK Investigational Site | Zhanjiang | 524001 | China |
| GSK Investigational Site | Zhanjiang | 524045 | China |
| GSK Investigational Site | Zhengzhou | 450000 | China |
| GSK Investigational Site | Zhongshan | 528400 | China |
| GSK Investigational Site | Zunyi | 563114 | China |
| Fluticasone Furoate [FF] 100 ug/ Umeclidinium [UMEC] 62.5 ug/ Vilanterol [VI] 25 ug |
Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate [FF] /62.5 ug umeclidinium [UMEC] /25 ug vilanterol [VI] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks. |
| FG002 | Fluticasone Furoate [FF] 200 ug / Vilanterol [VI] 25 ug | Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate [FF] and 25 ug Vilanterol [VI] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks. |
| FG003 | Fluticasone Furoate [FF] 200 ug/ Umeclidinium [UMEC] 62.5 ug/Vilanterol [VI] 25 ug | Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate [FF]/ 62.5 ug umeclidinium [UMEC] / 25 ug Vilanterol [VI] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks. |
| Safety | Safety population included all randomized participants who took at least 1 dose of study intervention. |
|
| Intent to Treat (ITT) Population | Intent to Treat (ITT) Population included all randomized participants, excluding those who were randomized in error. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat population includes all randomized participants, excluding-those who were randomized in error.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluticasone Furoate [FF] 100 Microgram[ug] / Vilanterol [VI] 25 ug | Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate [FF] and 25 ug vilanterol [VI] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks. |
| BG001 | Fluticasone Furoate [FF] 100 ug/ Umeclidinium [UMEC] 62.5 ug/ Vilanterol [VI] 25 ug | Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate [FF] /62.5 ug umeclidinium [UMEC] /25 ug vilanterol [VI] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks. |
| BG002 | Fluticasone Furoate [FF] 200 ug / Vilanterol [VI] 25 ug | Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate [FF] and 25 ug Vilanterol [VI] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks. |
| BG003 | Fluticasone Furoate [FF] 200 ug/ Umeclidinium [UMEC] 62.5 ug/Vilanterol [VI] 25 ug | Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate [FF]/ 62.5 ug umeclidinium [UMEC] / 25 ug Vilanterol [VI] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Intent-to-Treat (ITT) Population comprised of all randomized participants who received 100ug FF, excluding those who were randomized in error and did not receive the study drug. Only those participants with data available at specified time points have been analyzed. | Posted | Least Squares Mean | Standard Error | Liters | Baseline (pre-dose at Day 1) and Week 12 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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) | Intent-to-Treat (ITT) Population comprised of all randomized participants who received 200ug FF, excluding those who were randomized in error and did not receive the study drug. Only those participants with data available at specified time points have been analyzed | Posted | Least Squares Mean | Standard Error | Liters | Baseline (pre-dose at Day 1) and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Intent-to-Treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error and did not receive the study drug. Only those participants with data available at specified time points have been analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (pre-dose at Day 1) and Week 12 |
|
All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks.
Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention [any component]).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluticasone Furoate [FF] 100 Microgram[ug] / Vilanterol [VI] 25 ug | Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate [FF] and 25 ug vilanterol [VI] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks. | 0 | 91 | 2 | 90 | 16 | 90 |
| EG001 | Fluticasone Furoate [FF] 100 ug/ Umeclidinium [UMEC] 62.5 ug/ Vilanterol [VI] 25 ug | Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate [FF] /62.5 ug umeclidinium [UMEC] /25 ug vilanterol [VI] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks. | 0 | 90 | 3 | 90 | 18 | 90 |
| EG002 | Fluticasone Furoate [FF] 200 ug / Vilanterol [VI] 25 ug | Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate [FF] and 25 ug Vilanterol [VI] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks. | 0 | 89 | 3 | 89 | 22 | 89 |
| EG003 | Fluticasone Furoate [FF] 200 ug/ Umeclidinium [UMEC] 62.5 ug/Vilanterol [VI] 25 ug | Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate [FF]/ 62.5 ug umeclidinium [UMEC] / 25 ug Vilanterol [VI] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks. | 0 | 88 | 1 | 88 | 18 | 88 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis E | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Myocardial bridging | Congenital, familial and genetic disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v27.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2024 | Jul 24, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
|
| Posterior Mean |
| 0.076 |
| 2-Sided |
| 90 |
| 0.025 |
| 0.115 |
Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 100/62.5/25 and FF/VI 100/25 estimated in the MMRM analysis. |
| Other |
| Posterior Median | 0.079 | 2-Sided | 95 | 0.005 | 0.123 | Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 100/62.5/25 and FF/VI 100/25 estimated in the MMRM analysis. | Other |
|
|
|
| OG001 |
| Fluticasone Furoate [FF] 100 ug/ Umeclidinium [UMEC] 62.5 ug/ Vilanterol [VI] 25 ug |
Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate [FF] /62.5 ug umeclidinium [UMEC] /25 ug vilanterol [VI] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks. |
| OG002 | Fluticasone Furoate [FF] 200 ug / Vilanterol [VI] 25 ug | Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate [FF] and 25 ug Vilanterol [VI] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks. |
| OG003 | Fluticasone Furoate [FF] 200 ug/ Umeclidinium [UMEC] 62.5 ug/Vilanterol [VI] 25 ug | Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate [FF]/ 62.5 ug umeclidinium [UMEC] / 25 ug Vilanterol [VI] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks. |
|
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