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NCT05757102 | RECRUITING | Asthma

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

GlaxoSmithKline

Brief Summary:

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.

Condition or disease

Asthma

Intervention/treatment

FF/UMEC/VI

ELLIPTA

FF/VI

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 292 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-04-24
Estimated Primary Completion Date : 2027-01-15
Estimated Study Completion Date : 2027-01-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma

Location Details

NCT05757102

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

GSK Investigational Site

Birmingham, Albama, United States, 35209

RECRUITING

United States, Albama

GSK Investigational Site

Mobile, Albama, United States, 36608

RECRUITING

United States, Arizona

GSK Investigational Site

Paradise Valley, Arizona, United States, 85253

RECRUITING

United States, California

GSK Investigational Site

Bakersfield, California, United States, 93301

RECRUITING

United States, California

GSK Investigational Site

Mission Viejo, California, United States, 92691

COMPLETED

United States, California

GSK Investigational Site

Rolling Hills Estates, California, United States, 90274

RECRUITING

United States, Colorado

GSK Investigational Site

Colorado Springs, Colorado, United States, 80909

COMPLETED

United States, Florida

GSK Investigational Site

Aventura, Florida, United States, 33180

RECRUITING

United States, Florida

GSK Investigational Site

Miami, Florida, United States, 33165

COMPLETED

United States, Florida

GSK Investigational Site

Miami, Florida, United States, 33173

RECRUITING

United States, Florida

GSK Investigational Site

Miami, Florida, United States, 33174

RECRUITING

United States, Georgia

GSK Investigational Site

Savannah, Georgia, United States, 31406

RECRUITING

United States, Illinois

GSK Investigational Site

Normal, Illinois, United States, 61761

RECRUITING

United States, Kentucky

GSK Investigational Site

Owensboro, Kentucky, United States, 42301

RECRUITING

United States, Missouri

GSK Investigational Site

Columbia, Missouri, United States, 65203

RECRUITING

United States, Montana

GSK Investigational Site

Missoula, Montana, United States, 59808

RECRUITING

United States, New York

GSK Investigational Site

The Bronx, New York, United States, 10461

RECRUITING

United States, Ohio

GSK Investigational Site

Cincinnati, Ohio, United States, 45229

RECRUITING

United States, Ohio

GSK Investigational Site

Cleveland, Ohio, United States, 44106

RECRUITING

United States, Ohio

GSK Investigational Site

Dayton, Ohio, United States, 45404

RECRUITING

United States, Oklahola

GSK Investigational Site

Ololama City, Okholohan, United States, 73120

RECRUITING

United States, South Carolina

GSK Investigational Site

Charleston, South Carolina, United States, 29420

RECRUITING

United States, Texas

GSK Investigational Site

Dallas, Texas, United States, 75225-6301

RECRUITING

United States, Texas

GSK Investigational Site

Kerrville, Texas, United States, 78028

COMPLETED

United States, Texas

GSK Investigational Site

Plano, Texas, United States, 75034

COMPLETED

United States, Texas

GSK Investigational Site

Waco, Texas, United States, 76712

RECRUITING

Argentina,

GSK Investigational Site

San Miguel de Tucumán, Argentina, T4000Ihe

RECRUITING

Australia, Queensland

GSK Investigational Site

South Brisbane, Queensland, Australia, 4101

RECRUITING

Australia, Western Australia

GSK Investigational Site

It's a girl, Western Australia, Australia, 6027

RECRUITING

New Zealand,

GSK Investigational Site

Ebdentown, New Zealand, 5018

RECRUITING

South Korea,

GSK Investigational Site

Cheongju Chungcheongbuk-do, South Korea, 28644

RECRUITING

South Korea,

GSK Investigational Site

Gwangju, South Korea, 501-757

RECRUITING

South Korea,

GSK Investigational Site

Seoul, South Korea, 03722

RECRUITING

South Korea,

GSK Investigational Site

Seoul, South Korea, 05505

RECRUITING

South Korea,

GSK Investigational Site

Seoul, South Korea, 2447