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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
292
FF/UMEC/VI will be administered.
FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler
FF/VI will be administered.
Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24
FEV1 will be measured using spirometry.
Time frame: Baseline (Week 0) and Week 24
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.
Time frame: 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.
Time frame: 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.
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GSK Investigational Site
Birmingham, Alabama, United States
RECRUITINGGSK Investigational Site
Mobile, Alabama, United States
RECRUITINGGSK Investigational Site
Paradise Valley, Arizona, United States
RECRUITINGGSK Investigational Site
Bakersfield, California, United States
RECRUITINGGSK Investigational Site
Huntington Beach, California, United States
WITHDRAWNGSK Investigational Site
Mission Viejo, California, United States
RECRUITINGGSK Investigational Site
Rolling Hills Estates, California, United States
COMPLETEDGSK Investigational Site
Walnut Creek, California, United States
WITHDRAWNGSK Investigational Site
Colorado Springs, Colorado, United States
RECRUITINGGSK Investigational Site
Aventura, Florida, United States
COMPLETED...and 32 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 24