FF/UMEC/VI for Asthma in Teens Aged 12-17

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

Recruiting Phase 3 Interventional Study
Asthma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

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At a Glance
Age
12 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
292 (estimated)
Sponsor
GlaxoSmithKline · Industry
Who this trial is looking for

This trial is looking for teenagers with asthma who need regular medication to manage their symptoms. Participants will receive a new treatment for 24 weeks to see how well it helps their asthma.

Are You a Good Fit for This Trial?
Must be taking Inhaled corticosteroidsLong-Acting Beta2-Agonist

You may be able to join if

  • I am 12 to 17 years old.
  • I have been diagnosed with asthma for at least 1 year.
  • I have been using asthma medications daily for at least 12 weeks.
  • I have not changed my asthma medications in the last 6 weeks.
  • I have experienced asthma symptoms that needed healthcare attention in the last year.
  • I have poorly controlled asthma despite using my regular medications.
  • My lung function test results show I have a moderate level of asthma.

You may not be able to join if

  • I have had pneumonia in the last 6 weeks.
  • I have had a recent asthma flare that required a change in my treatment in the last 6 weeks.
  • I have a history of life-threatening asthma.
  • I have any other lung conditions besides asthma.
  • I am a current smoker or have used recreational inhaled products in the last 12 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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.

Trial Locations
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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 requ…
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