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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004801-28 | EudraCT Number |
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This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation powder once daily and VI inhalation powder once daily will be evaluated in subjects with COPD over 156 weeks. The primary objective of this study is to evaluate the effect of the inhaled corticosteroid FF on bone mineral density assessed at the total hip by comparing FF/VI treatment with VI treatment in subjects with moderate COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone Furoate/Vilanterol 100/25 micrograms (mcg) QD | Experimental | Subjects will self administer FF/VI 100/25 mcg inhalation powder once daily for 156 weeks via the NDPI. |
|
| Vilanterol 25 mcg QD | Experimental | Subjects will self administer VI 25 mcg inhalation powder once daily for 156 weeks via the NDPI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Furoate/Vilanterol | Drug | Dry white powder containing 100 mcg of Fluticasone Furoate blended with lactose per blister was administered by NDPI. Dry white powder containing 25 mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by NDPI. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Bone Mineral Density (BMD) Measured at Total Hip | BMD analysis performed on log (BMD ratio to baseline) using a repeated measures model with covariates of treatment group, age, gender, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100. | Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in BMD Measurements at Total Hip by Gender (Male Participants) | BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100. |
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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 | Jasper | Alabama | 35501 | United States | ||
| GSK Investigational Site |
A total of 482 participants were screened of which 199 were screen failures. A total of 283 participants were randomized in a 1:1 ratio to receive either VI or FF/VI.
The study was conducted on participants with chronic obstructive pulmonary disease (COPD) in five countries to assess the long-term safety effects of Fluticasone Furoate (FF) component of the FF/Vilanterol (VI) inhalation powder.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Administered VI | Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks. |
| FG001 | Participants Administered FF/VI |
| 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 | Aug 14, 2013 | Jan 15, 2019 |
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|
| Vilanterol | Drug | Dry white powder containing 25 mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by NDPI. |
|
| Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks |
| Percentage Change From Baseline in BMD Measurements at Total Hip by Gender (Female Participants) | BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100. | Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks |
| Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) by Gender (Male Participants) | BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100. | Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks |
| Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) by Gender (Female Participants) | BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100. | Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks |
| Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) | BMD analysis performed on log (BMD ratio to baseline) using a repeated measures model with covariates of treatment group, age, gender, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100. | Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33316 | United States |
| GSK Investigational Site | Lawrenceville | Georgia | 30046 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55402 | United States |
| GSK Investigational Site | Plymouth | Minnesota | 55441 | United States |
| GSK Investigational Site | Bellevue | Nebraska | 68123-4303 | United States |
| GSK Investigational Site | Wilmington | North Carolina | 28401 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Erie | Pennsylvania | 16508 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29406-7108 | United States |
| GSK Investigational Site | Old Point Station | South Carolina | 29707 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Chattanooga | Tennessee | 37404 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37919 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Spokane Valley | Washington | 99216 | United States |
| GSK Investigational Site | Sherwood Park | Alberta | T8H 0N2 | Canada |
| GSK Investigational Site | Winnipeg | Manitoba | R2H 2A6 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5T 3A9 | Canada |
| GSK Investigational Site | Québec | Quebec | G1V 4G5 | Canada |
| GSK Investigational Site | Saint-Charles-Borromée | Quebec | J6E 2B4 | Canada |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60596 | Germany |
| GSK Investigational Site | Neu-Isenburg | Hesse | 63263 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 51069 | Germany |
| GSK Investigational Site | Koblenz | Rhineland-Palatinate | 56068 | Germany |
| GSK Investigational Site | Berlin | 10787 | Germany |
| GSK Investigational Site | Berlin | 12157 | Germany |
| GSK Investigational Site | Hamburg | 22143 | Germany |
| GSK Investigational Site | Alkmaar | 1815 JD | Netherlands |
| GSK Investigational Site | Beek | 6191 JW | Netherlands |
| GSK Investigational Site | Ede | 6716 RP | Netherlands |
| GSK Investigational Site | Eindhoven | 5623 EJ | Netherlands |
| GSK Investigational Site | Hengelo | 7555 DL | Netherlands |
| GSK Investigational Site | Hoorn | 1624 NP | Netherlands |
| GSK Investigational Site | Losser | 7581 BV | Netherlands |
| GSK Investigational Site | Voerendaal | 6367 TM | Netherlands |
| GSK Investigational Site | Barcelona | Catalonia | 08017 | Spain |
| GSK Investigational Site | Alicante | 03004 | Spain |
| GSK Investigational Site | Barcelona | 08025 | Spain |
| GSK Investigational Site | L'Hospitalet de Llobregat | 08907 | Spain |
| GSK Investigational Site | Mérida (Badajoz) | 06800 | Spain |
| GSK Investigational Site | Ponferrada (León) | 24411 | Spain |
| GSK Investigational Site | Pozuelo de Alarcón/Madrid | 28223 | Spain |
| GSK Investigational Site | Salamanca | 37007 | Spain |
Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Administered VI | Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks. |
| BG001 | Participants Administered FF/VI | Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks. |
| BG002 | 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 | Safety population | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Safety population | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Safety population | Number | Count of 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 | Percentage Change From Baseline in Bone Mineral Density (BMD) Measured at Total Hip | BMD analysis performed on log (BMD ratio to baseline) using a repeated measures model with covariates of treatment group, age, gender, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).All randomized participants who received at least one dose of study treatment were included in Safety Population. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks |
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| Secondary | Percentage Change From Baseline in BMD Measurements at Total Hip by Gender (Male Participants) | BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks |
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| Secondary | Percentage Change From Baseline in BMD Measurements at Total Hip by Gender (Female Participants) | BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks |
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| Secondary | Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) by Gender (Male Participants) | BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks |
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| Secondary | Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) by Gender (Female Participants) | BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks |
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| Secondary | Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) | BMD analysis performed on log (BMD ratio to baseline) using a repeated measures model with covariates of treatment group, age, gender, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks |
|
Serious adverse events and non-serious adverse events were collected from randomization of the study until 159 weeks.
Safety Population. The non-serious AEs are reported using a frequency threshold of >3%.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants Administered VI | Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks. | 6 | 142 | 42 | 142 | 102 | 142 |
| EG001 | Participants Administered FF/VI | Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks. | 4 | 141 | 41 | 141 | 116 | 141 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Aortic valve stenosis | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Cardiac asthma | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Sinus node dysfunction | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Carpal tunnel syndrome | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Myoclonus | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Bladder cancer stage 0, with cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vesical fistula | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Contrast media reaction | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 21.0 | 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 | May 17, 2018 | Jan 15, 2019 | SAP_001.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C523187 | fluticasone furoate |
| C550468 | vilanterol |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| White |
|
| % change by Week 26, n= 130, 130 |
|
|
| % change by Week 52, n = 104, 121 |
|
|
| % change by Week 78, n = 97, 102 |
|
|
| % change by Week 104, n = 94, 96 |
|
|
| % change by Week 130, n = 88, 84 |
|
|
| % change by Week 156, n = 76, 75 |
|
|
|
|
|
|
|
|
Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.
|
|
|
Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.
|
|
|
|
|
|