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The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving FF/UMEC/VI | Experimental |
| |
| Participants receiving FF/VI | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FF/UMEC/VI | Drug | FF/UMEC/VI will be administered. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24 | FEV1 will be measured using spirometry. | Baseline (Week 0) and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale) | ACQ-7 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)), a question on rescue use and an additional item relating to lung function which is calculated based on FEV1. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | Birmingham | Alabama | 35209 | United States |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
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| ELLIPTA |
| Device |
FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler |
|
| FF/VI | Drug | FF/VI will be administered. |
|
| Baseline (Week 0) and Week 24 |
| Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale) | ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. | Baseline (Week 0) and Week 24 |
| Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale) | ACQ-5 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. | Baseline (Week 0) and Week 24 |
| Number of Participants with a clinically important change from baseline in ACQ-7 Score | ACQ-7 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)), a question on rescue use and an additional item relating to lung function which is calculated based on FEV1. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score. | Week 24 |
| Number of Participants with a clinically important change from baseline in ACQ-6 Score | ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score. | Week 24 |
| Number of Participants with a clinically important change from baseline in ACQ-5 Score | ACQ-5 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score. | Week 24 |
| GSK Investigational Site | Recruiting | Mobile | Alabama | 36608 | United States |
|
| GSK Investigational Site | Recruiting | Paradise Valley | Arizona | 85253 | United States |
|
| GSK Investigational Site | Recruiting | Bakersfield | California | 93301 | United States |
|
| GSK Investigational Site | Withdrawn | Huntington Beach | California | 92647 | United States |
| GSK Investigational Site | Recruiting | Mission Viejo | California | 92691 | United States |
|
| GSK Investigational Site | Completed | Rolling Hills Estates | California | 90274 | United States |
| GSK Investigational Site | Withdrawn | Walnut Creek | California | 94598 | United States |
| GSK Investigational Site | Recruiting | Colorado Springs | Colorado | 80909 | United States |
|
| GSK Investigational Site | Completed | Aventura | Florida | 33180 | United States |
| GSK Investigational Site | Recruiting | Miami | Florida | 33165 | United States |
|
| GSK Investigational Site | Completed | Miami | Florida | 33173 | United States |
| GSK Investigational Site | Recruiting | Miami | Florida | 33174 | United States |
|
| GSK Investigational Site | Completed | Savannah | Georgia | 31406 | United States |
| GSK Investigational Site | Recruiting | Normal | Illinois | 61761 | United States |
|
| GSK Investigational Site | Recruiting | Owensboro | Kentucky | 42301 | United States |
|
| GSK Investigational Site | Completed | Columbia | Missouri | 65203 | United States |
| GSK Investigational Site | Recruiting | Missoula | Montana | 59808 | United States |
|
| GSK Investigational Site | Recruiting | The Bronx | New York | 10461 | United States |
|
| GSK Investigational Site | Recruiting | Cincinnati | Ohio | 45229 | United States |
|
| GSK Investigational Site | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| GSK Investigational Site | Completed | Dayton | Ohio | 45404 | United States |
| GSK Investigational Site | Recruiting | Oklahoma City | Oklahoma | 73120 | United States |
|
| GSK Investigational Site | Recruiting | Charleston | South Carolina | 29420 | United States |
|
| GSK Investigational Site | Recruiting | Dallas | Texas | 75225-6301 | United States |
|
| GSK Investigational Site | Recruiting | Kerrville | Texas | 78028 | United States |
|
| GSK Investigational Site | Completed | Plano | Texas | 75034 | United States |
| GSK Investigational Site | Completed | Waco | Texas | 76712 | United States |
| GSK Investigational Site | Recruiting | Buenos Aires | C1023AAB | Argentina |
|
| GSK Investigational Site | Recruiting | Buenos Aires | C1425BEN | Argentina |
|
| GSK Investigational Site | Recruiting | Rosario | 2000 | Argentina |
|
| GSK Investigational Site | Recruiting | San Miguel de Tucumán | T4000IHE | Argentina |
|
| GSK Investigational Site | Recruiting | South Brisbane | Queensland | 4101 | Australia |
|
| GSK Investigational Site | Recruiting | Joondalup WA | Western Australia | 6027 | Australia |
|
| GSK Investigational Site | Recruiting | Santiago | 8320000 | Chile |
|
| GSK Investigational Site | Recruiting | Ebdentown | 5018 | New Zealand |
|
| GSK Investigational Site | Recruiting | Cheongju Chungcheongbuk-do | 28644 | South Korea |
|
| GSK Investigational Site | Withdrawn | Gwangju | 501-757 | South Korea |
| GSK Investigational Site | Completed | Seoul | 03722 | South Korea |
| GSK Investigational Site | Recruiting | Seoul | 05505 | South Korea |
|
| GSK Investigational Site | Withdrawn | Seoul | 1757 | South Korea |
| GSK Investigational Site | Recruiting | Seoul | 2447 | South Korea |
|
| 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 |
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