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NCT05757102Active, not 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

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
138 (estimated)
First submitted
24 Feb 2023
Start date
24 Apr 2023
Primary completion date
26 Jan 2027
Lead sponsor
GlaxoSmithKline
Diseases
Asthma
NCT number
NCT05757102

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 138
  • From 24 Apr 2023 to the primary completion date, 26 Jan 2027
  • 54 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • 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.

Other illness

  • 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.).

Who the study is looking for

  • 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.

Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (54)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Buenos AiresArgentinaUnknown status
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CórdobaArgentinaUnknown status
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LanusArgentinaUnknown status
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LobosArgentinaUnknown status
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Lujan de CuyoArgentinaUnknown status
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Mar del PlataArgentinaUnknown status
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RosarioArgentinaUnknown status
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Rosario Provincia de Santa FEArgentinaUnknown status
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San Miguel de TucumánArgentinaUnknown status
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Santa FeArgentinaUnknown status
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Joondalup WAAustraliaUnknown status
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North AdelaideAustraliaUnknown status
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South BrisbaneAustraliaUnknown status
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Lo BarnecheaChileUnknown status
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SantiagoChileUnknown status
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AshkelonIsraelUnknown status
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HaifaIsraelUnknown status
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Petah TikvaIsraelUnknown status
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Cheongju Chungcheongbuk-doSouth KoreaUnknown status
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GwangjuSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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GuadalajaraMexicoUnknown status
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MonterreyMexicoUnknown status
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San Juan del RíoMexicoUnknown status
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EbdentownNew ZealandUnknown status
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AventuraUnited StatesUnknown status
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BakersfieldUnited StatesUnknown status
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BirminghamUnited StatesUnknown status
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CharlestonUnited StatesUnknown status
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CincinnatiUnited StatesUnknown status
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ClevelandUnited StatesUnknown status
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Colorado SpringsUnited StatesUnknown status
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ColumbiaUnited StatesUnknown status
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DallasUnited StatesUnknown status
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DaytonUnited StatesUnknown status
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Huntington BeachUnited StatesUnknown status
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KerrvilleUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MilwaukeeUnited StatesUnknown status
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Mission ViejoUnited StatesUnknown status
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MissoulaUnited StatesUnknown status
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MobileUnited StatesUnknown status
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NormalUnited StatesUnknown status
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Oklahoma CityUnited StatesUnknown status
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OwensboroUnited StatesUnknown status
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Paradise ValleyUnited StatesUnknown status
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PlanoUnited StatesUnknown status
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Rolling Hills EstatesUnited StatesUnknown status
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SavannahUnited StatesUnknown status
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The BronxUnited StatesUnknown status
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WacoUnited StatesUnknown status
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AdanaTurkey (Türkiye)Unknown status
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AntalyaTurkey (Türkiye)Unknown status
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IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.