Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma

April 15, 2024 updated by: GlaxoSmithKline

A Phase 4, 52-week (Primary Analysis at 24-weeks), Randomized, Stratified, Open-label, Active-controlled, Parallel-group, Effectiveness Study, Comparing FF/UMEC/VI With Non-ellipta Usual Care (ICS/LABA) in Adult Participants With Uncontrolled Asthma

The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1136

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina, C1425BEN
        • GSK Investigational Site
        • Principal Investigator:
          • Anahi Yanez
        • Contact:
        • Contact:
      • Mendoza, Argentina, 5500
        • GSK Investigational Site
        • Principal Investigator:
          • Pablo Saez Scherbovsky
        • Contact:
        • Contact:
      • Rosario, Argentina, 2000
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gabriel Gattolin
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1192AAW
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Maria Stok
      • Florencio Varela, Buenos Aires, Argentina, 1888
        • GSK Investigational Site
        • Principal Investigator:
          • Andrea Cintia Medina
        • Contact:
        • Contact:
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luis Wehbe
    • Córdova
      • Cordoba, Córdova, Argentina, X5003DCE
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Victor Hugo Cambursano
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DBS
        • GSK Investigational Site
        • Principal Investigator:
          • Ledit R F Ardusso
        • Contact:
        • Contact:
      • Rosario, Santa Fe, Argentina, 2000
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adriana M. Marcipar
  • Australia
    • Australian Capital Territory
      • Bruce, Australian Capital Territory, Australia, 2617
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amber Leah
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rahul Mohan
      • Campbelltown, New South Wales, Australia, 2560
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Belinda Cochrane
      • Coffs Harbour, New South Wales, Australia, 2450
        • GSK Investigational Site
        • Principal Investigator:
          • Olga O Voloshyna
        • Contact:
        • Contact:
      • Kanwal, New South Wales, Australia, 2259
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dominic Douglas
    • Queensland
      • Brisbane, Queensland, Australia, 4006
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Esmond Leong
    • Western Australia
      • Spearwood, Western Australia, Australia, 6163
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter R Bremner
  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • GSK Investigational Site
        • Principal Investigator:
          • Naresh K. Aggarwal
        • Contact:
        • Contact:
      • Windsor, Ontario, Canada, N8X 1T3
        • GSK Investigational Site
        • Principal Investigator:
          • Syed Anees
        • Contact:
        • Contact:
    • Quebec
      • Trois-Rivieres, Quebec, Canada, G9A 4P3
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrice Gauthier
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N OW8
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Erika Dianne Penz
  • Japan
      • Fukuoka, Japan, 816-0813
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yuji Kawarada
      • Fukuoka, Japan, 802-0083
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shinichi Osaki
      • Gifu, Japan, 509-6134
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hiroyuki Ohbayashi
      • Hiroshima, Japan, 730-0853
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yoshinori Haruta
      • Hyogo, Japan, 651-0053
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hiroki Kawabata
      • Kagawa, Japan, 761-8073
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tadashi Kamei
      • Miyazaki, Japan, 880-2112
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rei Fujiki
      • Miyazaki, Japan, 889-4304
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kenjiro Nagai
      • Niigata, Japan, 950-0088
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yuki Nishiyama
      • Tokyo, Japan, 160-0017
        • GSK Investigational Site
        • Principal Investigator:
          • Takahiro Yokoyama
        • Contact:
        • Contact:
      • Tokyo, Japan, 157-0066
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Akiyoshi Sasamoto
      • Tokyo, Japan, 105-0001
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Akira Mizoo
  • Korea, Republic of
      • Daegu, Korea, Republic of, 41404
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Han-Ki Park
      • Seoul, Korea, Republic of, 07061
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Min-Suk Yang
      • Seoul, Korea, Republic of, 133-792
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sang-Heon Kim
      • Seoul, Korea, Republic of, 03080
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hye-Ryun Kang
      • Seoul, Korea, Republic of, 02841
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Byung-Keun Kim
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chau-Chyun Sheu
      • Taichung, Taiwan, 40447
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chia-Hung Chen
      • Taichung, Taiwan, 407219
        • GSK Investigational Site
        • Principal Investigator:
          • Pin-Kuei Fu
        • Contact:
        • Contact:
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karl V Sitz
    • California
      • Newport Beach, California, United States, 92663
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ryan Mitchell Klein
    • Florida
      • Miami, Florida, United States, 33173
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jaime Landman
      • Miami, Florida, United States, 33135
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Enrique Villa
      • Orlando, Florida, United States, 32819
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marvin Heuer
      • Port Charlotte, Florida, United States, 33952
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Ravid
      • Tallahassee, Florida, United States, 32308
        • GSK Investigational Site
        • Principal Investigator:
          • Ronald H. Saff
        • Contact:
        • Contact:
    • Georgia
      • Columbus, Georgia, United States, 31904
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert R Chrzanowski
    • Illinois
      • Normal, Illinois, United States, 61761
        • GSK Investigational Site
        • Principal Investigator:
          • Dareen Siri
        • Contact:
        • Contact:
    • Maine
      • Bangor, Maine, United States, 04401
        • GSK Investigational Site
        • Principal Investigator:
          • Paul Alan Shapero
        • Contact:
        • Contact:
    • Maryland
      • Columbia, Maryland, United States, 21044
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Nyanjom
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • GSK Investigational Site
        • Principal Investigator:
          • Bruce DeCotiis
        • Contact:
        • Contact:
      • Linwood, New Jersey, United States, 08221
        • GSK Investigational Site
        • Principal Investigator:
          • Allen Silvey
        • Contact:
        • Contact:
    • New York
      • New Windsor, New York, United States, 12553
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sashi Makam
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • GSK Investigational Site
        • Principal Investigator:
          • David Cypcar
        • Contact:
        • Contact:
      • Charlotte, North Carolina, United States, 28273
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emeka M Eziri
      • Greenville, North Carolina, United States, 27834
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bryan Dunn
      • Raleigh, North Carolina, United States, 27607
        • GSK Investigational Site
        • Principal Investigator:
          • Craig F LaForce
        • Contact:
        • Contact:
      • Winston-Salem, North Carolina, United States, 27104
        • GSK Investigational Site
        • Principal Investigator:
          • Wendy C Moore
        • Contact:
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David I Bernstein
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sadia Benzaquen
      • Philadelphia, Pennsylvania, United States, 19140
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kartik Shenoy
      • Pittsburgh, Pennsylvania, United States, 15241
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael J. Palumbo
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • GSK Investigational Site
        • Principal Investigator:
          • Michael Denenberg
        • Contact:
        • Contact:
      • Spartanburg, South Carolina, United States, 29303
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Farhan Siddiqui
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mark W Millard
      • Kerrville, Texas, United States, 78028
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dale E Mohar
      • Waco, Texas, United States, 76712
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Niran J. Amar

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Has a diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2022 guidelines for at least 3 months prior to randomization.

  2. Participants who are either:

    • Currently untreated
    • Treated with daily maintenance ICS or ICS/LABA
  3. ACQ-6 score ≥1.5 at randomization.
  4. Participants must be able to complete the study questionnaires.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  1. Recent history of life-threatening asthma
  2. History of >1 severe exacerbation of asthma within 12 months prior to randomization.
  3. Women of childbearing potential that are not following at least one highly effective method of contraception. This includes women who are pregnant or lactating or are planning on becoming pregnant during the study.
  4. A WOCBP must have a negative pregnancy test ≤7 days prior to randomization.
  5. Exposure to inhaler triple therapy [ICS + Long-acting muscarinic antagonist (LAMA) + LABA as Single inhaler triple therapy (SITT) or Multiple inhaler triple therapy(MITT)] and/or any LAMA-containing therapy within 12 months prior to randomization.
  6. Ongoing need for biologic therapy or recent use of a biologic therapy
  7. Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines.
  8. Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTA are not eligible to enter the study.
  9. Participants who are medically unable to withhold their albuterol/salbutamol for 6 hours prior to spirometry testing
  10. Changes in asthma medication (e.g., maintenance ICS/LABA) within 3 months prior to randomization.
  11. Participants with a history of hypersensitivity to any of the study medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI)
Drug: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate
Participants will receive FF/UMEC/VI
Active Comparator: Inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA)
Drug: Inhaled corticosteroids/long-acting beta-2 agonists
Participants will receive ICS/LABA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in trough forced expiratory volume in 1 second (FEV1)
Time Frame: Baseline (Day 1), and at Week 24
Baseline (Day 1), and at Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-7 (ACQ-7) after 24 weeks of treatment
Time Frame: Baseline (Day 1), and Week 24
The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation).Higher scores indicate greater impairment. ACQ-7 is the responder analysis based on a 0.5 point change.
Baseline (Day 1), and Week 24
Number of participants achieving the composite endpoint at Week in participants after 52 weeks of treatment
Time Frame: Up to 52 weeks

The 4-point composite endpoint is defined as meeting the following criteria:

  • Change from baseline in trough FEV1 ≥ 100 mL at Week 52.
  • Controlled asthma based on ACQ-5 total score ≤ 1.5 at Week 52.
  • No severe asthma exacerbations over 52 weeks.
  • OCS-free over 52 weeks
Up to 52 weeks
Change from baseline in trough forced expiratory volume in 1 second (FEV1) after 52 weeks of treatment
Time Frame: Baseline (Day 1), and Week 52
Baseline (Day 1), and Week 52
Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-7 after 52 weeks of treatment
Time Frame: Week 52
The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment. ACQ-7 is the responder analysis based on a 0.5 point change.
Week 52
Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-6 (ACQ-6) after 24 and 52 weeks of treatment
Time Frame: Baseline (Day 1), Week 24 and Week 52
The ACQ-6 is a shortened version of the ACQ-7 derived by removing one element (lung function element) from the original version. The scoring ranges from 0 (no impairment/ limitation) to 6 (total impairment/ limitation), higher scores indicate greater impairment. ACQ-6 is the responder analysis based on a 0.5 point change.
Baseline (Day 1), Week 24 and Week 52
Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-5 after 24 and 52 weeks of treatment
Time Frame: Baseline (Day 1), Week 24 and Week 52
The ACQ-5 consists of 5 questions scored from zero (no impairment/limitation) to six (total impairment/ limitation). Higher scores indicate greater impairment. It is a shorter version of ACQ-7 derived by removal of two elements (lung function and rescue use elements) from original version (ACQ-7). ACQ-5 is the responder analysis based on a 0.5 point change.
Baseline (Day 1), Week 24 and Week 52
Change from baseline in the ACQ-7 total score after 24 and 52 weeks of treatment
Time Frame: Baseline (Day 1), Week 24 and Week 52
The ACQ-7 total consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment.
Baseline (Day 1), Week 24 and Week 52
Change from baseline in the ACQ-5 total score after 24 and 52 weeks of treatment
Time Frame: Baseline (Day 1), Week 24 and Week 52
The ACQ-5 total consists of 5 questions scored from zero (no impairment/limitation) to six (total impairment/ limitation). Higher scores indicate greater impairment. It is a shorter version of ACQ-7 derived by removal of two elements (lung function and rescue use elements) from original version (ACQ-7).
Baseline (Day 1), Week 24 and Week 52
Change from baseline in the ACQ-6 total score after 24 and 52 weeks of treatment
Time Frame: Baseline (Day 1), Week 24 and Week 52
The ACQ-6 total is a shortened version of the ACQ-7 derived by removing one element (lung function element) from the original version. The scoring ranges from 0 (no impairment/limitation) to 6 (total impairment/ limitation), higher scores indicate greater impairment.
Baseline (Day 1), Week 24 and Week 52
Change from baseline in the Asthma Control Test (ACT) score after 24 and 52 weeks of treatment
Time Frame: Baseline (Day 1), Week 24 and Week 52
The ACT is a 5-question health survey used to measure asthma control in participants aged ≥12 years. Each question is scored from 1 to 5 for a total score ranging from 5 to 25; with higher scores indicating better asthma control.
Baseline (Day 1), Week 24 and Week 52
Number of participants achieving the composite endpoint among those on budesonide/formoterol prior to randomization
Time Frame: Up to 52 weeks

The 4-point composite endpoint is defined as meeting the following criteria:

  • Change from baseline in trough FEV1 ≥ 100 mL at Week 52.
  • Controlled asthma based on ACQ-5 total score ≤ 1.5 at Week 52.
  • No severe asthma exacerbations over 52 weeks.
  • OCS-free over 52 weeks
Up to 52 weeks
Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) total scores after 24 and 52 weeks of treatment
Time Frame: Baseline (Day 1), Week 24 and Week 52
The AQLQ (+12), is a modified version of the original AQLQ with standardized activities. The response scale ranges from 1 (totally impaired) to 7 (not at all impaired). The total score is the score from all 32 questions.
Baseline (Day 1), Week 24 and Week 52
Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) domain scores after 24 and 52 weeks of treatment
Time Frame: Baseline (Day 1), Week 24 and Week 52
The AQLQ (+12), is a modified version of the original AQLQ with standardized activities. The response scale ranges from 1 (totally impaired) to 7 (not at all impaired). The domain score looks at each domain individually - symptoms, activity limitation, emotional function and environmental stimuli.
Baseline (Day 1), Week 24 and Week 52
Change from baseline in the four domains of the asthma-specific adaptation of the Work Productivity and Activity Impairment Questionnaire (WPAI:Asthma) after 24 and 52 weeks of treatment
Time Frame: Baseline (Day 1), Week 24 and Week 52
WPAI is a self-administered tool to determine the degree to which asthma affected work productivity while at work and affected activities outside of work in the last 7 days. The WPAI questionnaire score represents the percentage of impairment, from 0 to 100%. Higher WPAI scores indicate greater activity impairment.
Baseline (Day 1), Week 24 and Week 52
Change from baseline in trough forced expiratory volume in 1 second (FEV1) among participants on budesonide/formoterol prior to randomization
Time Frame: Baseline (Day 1), and Week 24
Baseline (Day 1), and Week 24
Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 among participants on budesonide/formoterol prior to randomization
Time Frame: Baseline (Day 1), Week 24 and Week 52
The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment. ACQ-7 is the responder analysis based on a 0.5 point change.
Baseline (Day 1), Week 24 and Week 52
Change from baseline in the ACQ-7 total score among participants on budesonide/formoterol prior to randomization
Time Frame: Baseline (Day 1), Week 24 and Week 52
The ACQ-7 total consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment.
Baseline (Day 1), Week 24 and Week 52
Change from baseline in trough forced expiratory volume in 1 second (FEV1) for participants with no treatment prior to randomization.
Time Frame: Baseline (Day 1), and Week 24
Baseline (Day 1), and Week 24
Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 for participants with no treatment prior to randomization.
Time Frame: Baseline (Day 1), Week 24 and Week 52
The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment. ACQ-7 is the responder analysis based on a 0.5 point change.
Baseline (Day 1), Week 24 and Week 52
Change from baseline in the ACQ-7 total score for participants with no treatment prior to randomization.
Time Frame: Baseline (Day 1), Week 24 and Week 52
The ACQ-7 total consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment. s
Baseline (Day 1), Week 24 and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 Major Dates

Study Start (Estimated)

April 16, 2024

Primary Completion (Estimated)

March 11, 2026

Study Completion (Estimated)

March 11, 2026

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 219912

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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