A Phase IV, 12 Week, Randomised, Double-blind, Double-dummy Study to Compare Single Inhaler Triple Therapy, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI), With Tiotropium Monotherapy Based on Lung Function and Symptoms in Participants With Chronic Obstructive Pulmonary Disease

Status: Completed
Location: See all (72) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

COPD is a progressive disease characterized by increasing obstruction to airflow and the progressive development of respiratory symptoms including chronic cough, increased sputum production, dyspnea and wheezing. Once-daily triple therapy of an Inhaled Corticosteroid/ Long-acting Muscarinic Receptor Antagonists/ Long Acting Beta-Agonist (ICS/LAMA/LABA) that is combination of FF/UMEC/VI in a single device is being developed with the aim of providing a new treatment option for the management of advanced COPD. The primary purpose of this study is to evaluate lung function and health related quality of life (HRQoL) after 84 days of treatment with a single inhaler triple therapy combination of FF/ UMEC/VI once daily via the ELLIPTA® dry powder inhaler (DPI) compared with tiotropium once daily via HANDIHALER®, in subjects with COPD. Subjects will be randomized 1:1 to receive FF/UMEC/VI or tiotropium in the morning for 84 days. Subjects will also receive albuterol/salbutamol as a rescue therapy throughout the study. Approximately 848 subjects with advanced COPD will be enrolled in the study. The total study duration will be approximately 17 weeks including, 4-week run-in period, 12-week treatment period and a 1-week follow-up period. ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of companies. HANDIHALER and RESPIMAT are registered trademarks of Boeringher Ingelheim.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
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• Subjects capable of giving signed informed consent.

• Outpatients will be included in the study.

• Subjects 40 years of age or older at Screening (Visit 1).

• Male or female subjects will be included; a female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period and until the safety follow-up contact after the last dose of study treatment.

• An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society.

• Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at Screening (Visit 1) (number of pack years = \[number of cigarettes per day / 20\] x number of years smoked \[example given {e.g.}, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years\]). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.

• A score of \>=10 on the COPD Assessment Test (CAT) at Screening (Visit 1).

• Subjects must demonstrate at Screening: A post-bronchodilator FEV1 \<50 percent predicted normal or a post-bronchodilator FEV1 \<80 percent predicted normal and a documented history of \>=2 moderate exacerbations or one severe (hospitalized) exacerbation in the previous 12 months. Subjects must also have a measured post albuterol/salbutamol FEV1/forced vital capacity (FVC) ratio of \<0.70 at screening.

• Subjects must have been receiving daily maintenance treatment with tiotropium alone (via the HANDIHALER or RESPIMAT®) for their COPD for at least 3 months prior to Screening.

Locations
United States
Alabama
GSK Investigational Site
Andalusia
California
GSK Investigational Site
Huntington Beach
GSK Investigational Site
Sacramento
GSK Investigational Site
Simi Valley
Colorado
GSK Investigational Site
Colorado Springs
Florida
GSK Investigational Site
Daytona Beach
GSK Investigational Site
Kissimmee
GSK Investigational Site
Miami
GSK Investigational Site
Miami
GSK Investigational Site
Miami Lakes
GSK Investigational Site
Orlando
GSK Investigational Site
Ormond Beach
GSK Investigational Site
Panama City
Idaho
GSK Investigational Site
Nampa
Maryland
GSK Investigational Site
Oxon Hill
Minnesota
GSK Investigational Site
Edina
GSK Investigational Site
Minneapolis
North Carolina
GSK Investigational Site
Gastonia
New York
GSK Investigational Site
Bronxville
GSK Investigational Site
Fayetteville
Ohio
GSK Investigational Site
Cincinnati
GSK Investigational Site
Dublin
Pennsylvania
GSK Investigational Site
Dubois
South Carolina
GSK Investigational Site
Anderson
GSK Investigational Site
Gaffney
GSK Investigational Site
Greer
GSK Investigational Site
Little River
GSK Investigational Site
Pelzer
GSK Investigational Site
Seneca
GSK Investigational Site
Spartanburg
Texas
GSK Investigational Site
Corsicana
GSK Investigational Site
Huntsville
Utah
GSK Investigational Site
Salt Lake City
Other Locations
Poland
GSK Investigational Site
Bialystok
GSK Investigational Site
Bialystok
GSK Investigational Site
Bielsko-biala
GSK Investigational Site
Bydgoszcz
GSK Investigational Site
Bydgoszcz
GSK Investigational Site
Chojnice
GSK Investigational Site
Grudziadz
GSK Investigational Site
Kielce
GSK Investigational Site
Krakow
GSK Investigational Site
Krakow
GSK Investigational Site
Lublin
GSK Investigational Site
Nowa Sol
GSK Investigational Site
Ostroda
GSK Investigational Site
Ostrowiec Swietokrzyski
GSK Investigational Site
Piaseczno
GSK Investigational Site
Proszowice
GSK Investigational Site
Siedlce
GSK Investigational Site
Skierniewice
GSK Investigational Site
Sopot
GSK Investigational Site
Swidnica
GSK Investigational Site
Szczecin
GSK Investigational Site
Torun
GSK Investigational Site
Warszawa
GSK Investigational Site
Zamosc
GSK Investigational Site
Zawadzkie
Russian Federation
GSK Investigational Site
Ekaterinburg
GSK Investigational Site
Ivanovo
GSK Investigational Site
Moscow
GSK Investigational Site
Moscow
GSK Investigational Site
Moscow
GSK Investigational Site
Novosibirsk
GSK Investigational Site
Novosibirsk
GSK Investigational Site
Saint Petersburg
GSK Investigational Site
Saint Petersburg
GSK Investigational Site
Saratov
GSK Investigational Site
St Petersburg
GSK Investigational Site
St-petersburg
GSK Investigational Site
Ulyanovsk
GSK Investigational Site
Voronezh
Time Frame
Start Date: 2018-03-29
Completion Date: 2019-07-17
Participants
Target number of participants: 800
Treatments
Experimental: Subjects receiving FF/UMEC/VI + Placebo to match tiotropium
Eligible subjects will receive FF/UMEC/VI at a dose of 100/62.5/25 microgram (mcg) administered once daily in the morning via ELLIPTA along with placebo to match tiotropium administered once daily in the morning via HANDIHALER. Subjects will self-administer 4 puffs of rescue medication (Albuterol/salbutamol) via metered dose inhaler (MDI).
Experimental: Subjects receiving Tiotropium + Placebo to match FF/UMEC/VI
Eligible subjects will receive Tiotropium at a dose of 18 mcg administered once daily in the morning via HANDIHALER along with placebo to match FF/UMEC/VI administered once daily in the morning via ELLIPTA. Subjects will self-administer 4 puffs of rescue medication (Albuterol/salbutamol) via MDI.
Sponsors
Collaborators: Parexel
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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