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The purpose of the study is to investigate the efficacy and safety of fluticasone furoate/vilanterol Inhalation Powder compared with placebo over a 24 weeks treatment period in subjects of Asian ancestry with Chronic Obstructive Pulmonary Disease (COPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fluticasone furoate/vilanterol | Experimental | Inhaled corticosteroid/long acting beta-agonist |
|
| placebo | Placebo Comparator | matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone furoate/vilanterol | Drug | Inhaled corticosteroid/long acting beta-agonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169 | Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 was defined as the pre-dose and pre-bronchodilator FEV1, which was obtained at each clinic visit. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing at each clinic visit. Change from Baseline was calculated as the average at each clinic visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), baseline - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, day, day by baseline and day by treatment interactions. | Baseline to Day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Domain Score at Day 168 | CRQ-SAS measures 4 domains (fatigue, emotional function, mastery and dyspnea) of functioning of participants (par.) with COPD: mastery (amount of control the par. feels he/she has over COPD symptoms); fatigue (how tired the par. feels); emotional function (how anxious/depressed the par. feels); and dyspnea (how short of breath the par. feels during physical activities). Each domain is calculated separately and measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Dyspnea domain score is the mean of all non-missing responses for that domain. Only the dyspnea domain was measured as a secondary outcome. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average of the Day 168 values minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), day, day by BL, and day by treatment interactions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Guangzhou | Guangdong | 510120 | China | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25830381 | Derived | Zheng J, de Guia T, Wang-Jairaj J, Newlands AH, Wang C, Crim C, Zhong N. Efficacy and safety of fluticasone furoate/vilanterol (50/25 mcg; 100/25 mcg; 200/25 mcg) in Asian patients with chronic obstructive pulmonary disease: a randomized placebo-controlled trial. Curr Med Res Opin. 2015 Jun;31(6):1191-200. doi: 10.1185/03007995.2015.1036016. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 113684 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Eligible participants (par.) completed a 2-week Run-in Period for symptom scores at baseline and to establish a stable baseline. Par. were then randomized to a 24-week (wk) Treatment Period. 880 par. were screened, 744 entered the RIP and 646 par were randomized, out of which 643 par received >=1 study treatment dose.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo- Run-in | Participants received placebo once daily (OD) in the morning for 2 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 2-wk Single-blind Placebo Run-in Period |
|
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| Placebo | Drug | matching placebo |
|
| Baseline (BL) and Day 168 |
| Guangzhou |
| Guangdong |
| 510515 |
| China |
| GSK Investigational Site | Nanning | Guangxi | 530021 | China |
| GSK Investigational Site | Changsha | Hunan | 410011 | China |
| GSK Investigational Site | Shenyang | Liaoning | 110001 | China |
| GSK Investigational Site | Shenyang | Liaoning | 110015 | China |
| GSK Investigational Site | Xi'an | Shaanxi | 710032 | China |
| GSK Investigational Site | Xi'an | Shaanxi | 710061 | China |
| GSK Investigational Site | Hangzhou | Zhejiang | 310003 | China |
| GSK Investigational Site | Beijing | 100020 | China |
| GSK Investigational Site | Beijing | 100034 | China |
| GSK Investigational Site | Beijing | 100048 | China |
| GSK Investigational Site | Beijing | 100191 | China |
| GSK Investigational Site | Changsha | 410013 | China |
| GSK Investigational Site | Chengdu | 610041 | China |
| GSK Investigational Site | Chongqing | 400037 | China |
| GSK Investigational Site | Chongqing | 400038 | China |
| GSK Investigational Site | Shanghai | 200025 | China |
| GSK Investigational Site | Shanghai | 200080 | China |
| GSK Investigational Site | Shanghai | 200433 | China |
| GSK Investigational Site | Tianjin | 300052 | China |
| GSK Investigational Site | Quezon City | 1100 | Philippines |
| GSK Investigational Site | Quezon City | 1109 | Philippines |
| GSK Investigational Site | Jeonju-si, Jeollabuk-Do | 561-712 | South Korea |
| GSK Investigational Site | Seoul | 158-710 | South Korea |
| GSK Investigational Site | Suwon, Gyeonggi-do | 442-723 | South Korea |
| GSK Investigational Site | Changhua | 500 | Taiwan |
| GSK Investigational Site | Kaohsiung City | 833 | Taiwan |
| GSK Investigational Site | Taichung | 40201 | Taiwan |
| GSK Investigational Site | Taichung | 404 | Taiwan |
| GSK Investigational Site | Taichung | 40705 | Taiwan |
| GSK Investigational Site | Taipei | 100 | Taiwan |
| GSK Investigational Site | Taipei | 112 | Taiwan |
| GSK Investigational Site | Tau-Yuan County | 333 | Taiwan |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113684 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113684 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113684 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113684 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113684 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113684 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study. |
| FG002 | FF /VI 50/25 µg OD | Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study. |
| FG003 | FF/VI 100/25 µg OD | Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study. |
| FG004 | FF/VI 200/25 µg OD | Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study. |
| COMPLETED |
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| NOT COMPLETED |
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| 24-week, Double-blind Treatment Period |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study. |
| BG001 | FF /VI 50/25 µg OD | Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study. |
| BG002 | FF/VI 100/25 µg OD | Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study. |
| BG003 | FF/VI 200/25 µg OD | Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study. |
| 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 |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169 | Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 was defined as the pre-dose and pre-bronchodilator FEV1, which was obtained at each clinic visit. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing at each clinic visit. Change from Baseline was calculated as the average at each clinic visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), baseline - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, day, day by baseline and day by treatment interactions. | Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represents those with data available at the time point being presented, however, all par. in the ITT population without missing covariate information with at least one post BL measurement are included in the analysis. | Posted | Least Squares Mean | Standard Error | Liters | Baseline to Day 169 |
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| Secondary | Mean Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Domain Score at Day 168 | CRQ-SAS measures 4 domains (fatigue, emotional function, mastery and dyspnea) of functioning of participants (par.) with COPD: mastery (amount of control the par. feels he/she has over COPD symptoms); fatigue (how tired the par. feels); emotional function (how anxious/depressed the par. feels); and dyspnea (how short of breath the par. feels during physical activities). Each domain is calculated separately and measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Dyspnea domain score is the mean of all non-missing responses for that domain. Only the dyspnea domain was measured as a secondary outcome. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average of the Day 168 values minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), day, day by BL, and day by treatment interactions. | ITT Population. Only those participants available at the indicated time point were assessed. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (BL) and Day 168 |
|
Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to Week 24).
An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of the study medication.
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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 | Placebo | Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study. | 14 | 162 | 27 | 162 | ||
| EG001 | FF/VI 50/25 µg OD | articipants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study. | 9 | 160 | 33 | 160 | ||
| EG002 | FF/VI 100/25 µg OD | Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study. | 7 | 161 | 34 | 161 | ||
| EG003 | FF/VI 200/25 µg OD | Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study. | 14 | 160 | 40 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Burns third degree | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Gastric cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Renal embolism | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal infarct | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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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 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C523187 | fluticasone furoate |
| C550468 | vilanterol |
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| Lack of Efficacy |
|
| Protocol Violation |
|
| Met Protocol-Defined Stopping Criteria |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Male |
|
| Asian - South East Asian |
|
Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM) |
| <0.001 |
| Least Squares Mean Difference |
| 0.179 |
| 2-Sided |
| 95 |
| 0.129 |
| 0.230 |
| No |
| Superiority or Other |
| Mixed Models Analysis | Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM) | <0.001 | Least Squares Mean Difference | 0.194 | 2-Sided | 95 | 0.143 | 0.245 | No | Superiority or Other |
| FF/VI 50/25 µg OD |
Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study. |
| OG002 | FF/VI 100/25 µg OD | Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study. |
| OG003 | FF/VI 200/25 µg OD | Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study. |
|
|