RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2023-04-24
Study Completion:2027-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05757102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Participant must be 12 to 17 years of age (inclusive), at the time of signing the informed consent/assent.
  2. * 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.
  3. * 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).
  4. * 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).
  5. * Participants with inadequately controlled asthma (ACQ-6 score ≥1.5) at Visit 1, despite ICS/LABA maintenance therapy.
  6. * 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.
  1. * Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
  2. * 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)
  3. * History of Life-threatening Asthma
  4. * Participants with current evidence of active pulmonary diseases or abnormalities other than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis, etc.).
  5. * 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.

Contacts and Locations

Study Contact

US GSK Clinical Trials Call Center
CONTACT
877-379-3718
GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center
CONTACT
+44 (0) 20 89904466
GSKClinicalSupportHD@gsk.com

Principal Investigator

GSK Clinical Trials
STUDY_DIRECTOR
GlaxoSmithKline

Study Locations (Sites)

GSK Investigational Site
Birmingham, Alabama, 35209
United States
GSK Investigational Site
Mobile, Alabama, 36608
United States
GSK Investigational Site
Paradise Valley, Arizona, 85253
United States
GSK Investigational Site
Phoenix, Arizona, 85014
United States
GSK Investigational Site
Bakersfield, California, 93301
United States
GSK Investigational Site
Huntington Beach, California, 92647
United States
GSK Investigational Site
Mission Viejo, California, 92691
United States
GSK Investigational Site
Rolling Hills Estates, California, 90274
United States
GSK Investigational Site
Walnut Creek, California, 94598
United States
GSK Investigational Site
Colorado Springs, Colorado, 80909
United States
GSK Investigational Site
Denver, Colorado, 80206
United States
GSK Investigational Site
Aventura, Florida, 33180
United States
GSK Investigational Site
Miami Lakes, Florida, 33016
United States
GSK Investigational Site
Miami, Florida, 33165
United States
GSK Investigational Site
Miami, Florida, 33173
United States
GSK Investigational Site
Miami, Florida, 33174
United States
GSK Investigational Site
Orlando, Florida, 32822
United States
GSK Investigational Site
Savannah, Georgia, 31406
United States
GSK Investigational Site
Normal, Illinois, 61761
United States
GSK Investigational Site
Louisville, Kentucky, 40202
United States
GSK Investigational Site
Owensboro, Kentucky, 42301
United States
GSK Investigational Site
Columbia, Missouri, 65203
United States
GSK Investigational Site
Missoula, Montana, 59808
United States
GSK Investigational Site
Ocean City, New Jersey, 07712
United States
GSK Investigational Site
Albany, New York, 12208
United States
GSK Investigational Site
Bronx, New York, 10461
United States
GSK Investigational Site
E. Amherst, New York, 14051
United States
GSK Investigational Site
Cincinnati, Ohio, 45229
United States
GSK Investigational Site
Cleveland, Ohio, 44106
United States
GSK Investigational Site
Dayton, Ohio, 45404
United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
United States
GSK Investigational Site
North Charleston, South Carolina, 29420
United States
GSK Investigational Site
Boerne, Texas, 78006
United States
GSK Investigational Site
Dallas, Texas, 75225-6301
United States
GSK Investigational Site
Frisco, Texas, 75034
United States
GSK Investigational Site
Kerrville, Texas, 78028
United States
GSK Investigational Site
Waco, Texas, 76712
United States
GSK Investigational Site
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

  • GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-24
Study Completion Date2027-01-15

Study Record Updates

Study Start Date2023-04-24
Study Completion Date2027-01-15

Terms related to this study

Keywords Provided by Researchers

  • Fluticasone Furoate
  • GW685698
  • Umeclidinium
  • GSK573719
  • Vilanterol
  • GW642444
  • Trelegy
  • Relvar
  • Breo

Additional Relevant MeSH Terms

  • Asthma