RecruitingPhase 3

A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two asthma treatments: FF/UMEC/VI and FF/VI. It looks at how well they improve lung function after 24 weeks, along with safety and side effects. It is for teens ages 12–17 whose asthma is not well controlled with daily treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 12–17 years old when signing the study consent or agreement form.
  • Have an asthma diagnosis for at least 1 year before Visit 0.
  • Have used daily inhaled steroids and a long-acting medicine that opens the airways for at least 12 weeks before Visit 0.
  • Have no changes to regular asthma medicines in the 6 weeks before Visit 0. The daily steroid dose must be more than 250 and no more than 500 micrograms of fluticasone propionate, or an equal dose of another steroid.
  • In the year before Visit 1, have a recorded healthcare contact for sudden asthma symptoms, or a recorded short-term treatment change under an asthma action plan.
  • Have asthma that is not well controlled despite daily treatment, with an asthma control questionnaire score of at least 1.5 at Visit 1.
  • At Visit 1, have a breathing test result above 40% and no more than 90% of the expected normal value before airway-opening medicine. The result must improve by at least 12% after albuterol or salbutamol.

Who can't join

  • Have pneumonia confirmed by a chest X-ray in the 6 weeks before Visit 1.
  • Have an asthma flare-up in the 6 weeks before Visit 1 that required a change in regular treatment or steroid pills or injections for at least 3 days. A short-term treatment change may be allowed if you return to your usual treatment and asthma condition, and the study doctor decides you can safely join.
  • Have a history of life-threatening asthma.
  • Have an active lung disease or lung problem other than asthma, such as pneumonia or active tuberculosis.
  • Have smoked or used inhaled products for recreation in the 12 months before Visit 1. This includes cigarettes, e-cigarettes, vaping devices, cigars, and pipes, with or without nicotine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (28)

AL

AZ

CA

CO

FL

GA

IL

KY

MO

MT

NY

OH

OK

SC

TX

WI