A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
ConditionAsthma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-17
SponsorGlaxoSmithKline
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.).
Trial design
Design model
Parallel
Treatments tested in this trial
FF/UMEC/VI
DrugFF/UMEC/VI will be administered.
ELLIPTA
DeviceFF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler
FF/VI
DrugFF/VI will be administered.
Treatment groups
292 Participants
are divided into 2 treatment groupsGroup A: Participants receiving FF/UMEC/VIExperimental treatment 2 interventions
Group B: Participants receiving FF/VIActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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 24Secondary outcomes
1
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 242
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 243
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.
Time frame
Baseline (Week 0) and Week 244
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 24Sponsors and contacts
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Source ClinicalTrials.gov