Last updated: 10/06/2025 15:20:08
A study to compare the efficacy, safety and tolerability of FF/UMEC/VI with FF/VI in 12–17-year-olds with asthma
GSK study ID
206867
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: A Phase 3, 24-week, randomized, double-blind, parallel-group Bayesian Dynamic Borrowing study comparing the efficacy, safety, tolerability and pharmacokinetics of FF/UMEC/VI with FF/VI in 12-17-year-old participants with inadequately controlled asthma on stable maintenance therapy with ICS/LABA
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24
Timeframe: Baseline (Week 0) and Week 24
Secondary outcomes:
Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)
Timeframe: Baseline (Week 0) and Week 24
Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale)
Timeframe: Baseline (Week 0) and Week 24
Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale)
Timeframe: Baseline (Week 0) and Week 24
Number of Participants with a clinically important change from baseline in ACQ-7 Score
Timeframe: Week 24
Number of Participants with a clinically important change from baseline in ACQ-6 Score
Timeframe: Week 24
Number of Participants with a clinically important change from baseline in ACQ-5 Score
Timeframe: Week 24
Interventions:
Enrollment:
292
Primary completion date:
2027-15-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
April 2023 to January 2027
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12 - 17 Years
Accepts healthy volunteers
No
- 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.
- 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)
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Cheongju Chungcheongbuk-do, South Korea, 28644
Status
Recruiting
Location
GSK Investigational Site
Rolling Hills Estates, CA, United States, 90274
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, CO, United States, 80909
Status
Recruiting
Location
GSK Investigational Site
San Miguel de TucumAn, Argentina, T4000IHE
Status
Recruiting
Location
GSK Investigational Site
Huntington Beach, CA, United States, 92647
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Walnut Creek, CA, United States, 94598
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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