Asthma
Conditions
Keywords
Fluticasone Furoate, GW685698, Umeclidinium, GSK573719, Vilanterol, GW642444, Trelegy, Relvar, Breo
Brief summary
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.
Interventions
DRUGFF/UMEC/VI
FF/UMEC/VI will be administered.
DEVICEELLIPTA
FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler
DRUGFF/VI
FF/VI will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Participant must be 12 to 17 years of age (inclusive), at the time of signing the informed consent/assent. * Participants who have a diagnosis of asthma as defined by the National Institutes of Health \[NIH, 2020\] at least 1 year prior to Visit 0. * Participants who have required daily Inhaled corticosteroids (ICS)/ Long-Acting Beta2-Agonist (LABA) treatment for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total ICS dose of \>250 to \<=500 microgram (mcg)/day fluticasone propionate, or equivalent). * In the 1 year prior to Visit 1: A documented healthcare contact for acute asthma symptoms; OR A documented temporary change in asthma therapy for acute asthma symptoms, according to a prespecified asthma action plan (or equivalent). * Participants with inadequately controlled asthma (ACQ-6 score ≥1.5) at Visit 1, despite ICS/LABA maintenance therapy. * A best pre-bronchodilator FEV1 \>40% to \<=90% of the predicted normal value and a ≥12% increase in FEV1 with albuterol/salbutamol at Visit 1. Predicted values will be based on the European Respiratory Society (ERS) Global Lung Function Initiative.
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 and/or the use of systemic corticosteroids for at least 3 days in the 6 weeks prior to Visit 1. (Participants requiring a temporary change in asthma therapy (e.g., oral corticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator's discretion, the participant's condition is stable after they have resumed their pre-exacerbation maintenance asthma therapy (without modification), returned to their baseline asthma status and they are considered appropriate for enrollment into this study of up to 6 months duration) * History of Life-threatening Asthma * Participants with current evidence of active pulmonary diseases or abnormalities other than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis, etc.). * Current smokers and users of other inhaled products for recreation with or without nicotine (defined as participants who use cigarettes, e-cigarettes, other/vaping-related devices, cigars or pipe tobacco\]) within 12 months prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24 | Baseline (Week 0) and Week 24 | FEV1 will be measured using spirometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale) | Baseline (Week 0) and Week 24 | 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. |
| Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale) | Baseline (Week 0) and Week 24 | 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. |
| Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale) | Baseline (Week 0) and Week 24 | 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. |
| Number of Participants with a clinically important change from baseline in ACQ-6 Score | Week 24 | 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. |
| Number of Participants with a clinically important change from baseline in ACQ-5 Score | Week 24 | 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. |
| Number of Participants with a clinically important change from baseline in ACQ-7 Score | Week 24 | 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. |
Countries
Argentina, Australia, Chile, New Zealand, South Korea, United States
Contacts
Primary ContactUS GSK Clinical Trials Call Center
Backup ContactEU GSK Clinical Trials Call Center
Outcome results
None listed