The Clinical Effectiveness of Fluticasone Furoate/Umeclidinium
Bromide/Vilanterol in a Single Inhaler (TRELEGY ELLIPTA) when Compared
with Non-ELLIPTA Multiple Inhaler Triple Therapies in COPD Patients within a Usual
Care Setting.(study 206854)
Published:
Last updated:
Primary:To compare the effectiveness of TRELEGY ELLIPTA with non-ELLIPTA MITT for the impact of COPDon wellbeing and daily life after 24 weeks* treatment. Secondary:To compare the effectiveness of TRELEGY ELLIPTA with non-ELLIPTA MITT on lung…
Change from baseline in COPD Assessment Test (CAT) after 24 weeks of treatment.
Secondary outcome
Change from baseline in FEV1 at 24 weeks (subgroup of patients, not in NL).
Percentage of participants making at least 1 critical error in inhalation
technique (subgroup of patients, not in NL)..
Background summary
The highly-controlled conditions of a randomized clinical trial (RCT) remove factors that influence and differentiate the use of medicines in everyday clinical practice. Effectiveness data generated in the broader population observed in an everyday clinical setting is increasingly being recognized as important in complementing data derived from the pivotal Phase III safety and efficacy studies. The primary purpose of this study is to assess the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA Multiple Inhaler Triple Therapies (MITT) for Chronic Obstructive Pulmonary Disease (COPD) control within the usual clinical practice setting. The study will be conducted once TRELEGY ELLIPTA has been approved in the countries in which the study will be conducted and is available commercially.
Study objective
Primary: To compare the effectiveness of TRELEGY ELLIPTA with non-ELLIPTA MITT for the impact of COPD on wellbeing and daily life after 24 weeks* treatment. Secondary: To compare the effectiveness of TRELEGY ELLIPTA with non-ELLIPTA MITT on lung function after 24 weeks* treatment (substudy not to be conducted in NL). To compare critical errors made by study participants using the ELLIPTA device with participants using selected non-ELLIPTA MITT after 24 weeks* treatment (substudy not to be conducted in NL). Safety.
Study design
Open-label, randomized, parallel group phase IV effectiveness study with 2 arms. Randomization to treatment with: 1. Trelegy ELLIPTA (Fluticasone Furoate/ Umeclidinium Bromide/Vilanterol 100mcg/62.5mcg/25mcg in the ELLIPTA inhaler) once daily for 24 weeks. 2. Non-ELLIPTA Multiple Inhaler Triple Therapy (MITT) for COPD for 24 weeks. 3.000 subjects (3.400 to be screened).
Intervention
Treatment with Trelegy ELLIPTA or Non-ELLIPTA MITT.
Study burden and risks
Risk: Adverse events of study medication. Burden: 2 visits in 24 weeks. Questionnaires: signs and symptoms and quality of life (twice), subject*s satisfaction with health and treatment (once).
Public
GlaxoSmithKline
Huis ter Heideweg 62 Zeist 3705 LZ NL
Scientific
GlaxoSmithKline
Huis ter Heideweg 62 Zeist 3705 LZ NL
Listed location countries
Netherlands
Age
Adults (18-64 years)
Elderly (65 years and older)
Inclusion criteria
* Males and females *40 years of age. * Documented diagnosis of COPD. * COPD Assessment Test (CAT) *10 at screening. * At least one moderate to severe exacerbation in the past 3 years. * Continuous treatment for at least 60 days during the past 16 weeks with inhaled corticosteroid plus long-acting *2-agonist plus long-acting muscarinic antagonist or long-acting *2-agonist plus long-acting muscarinic antagonist or inhaled corticosteroid plus long-acting *2-agonist. In case of dual therapy: A documented indication for triple therapy must be present.
Exclusion criteria
* Woman of childbearing potential. See protocol page 27 for details. * Unstable COPD. See protocol page 27 for details. * Chronic use of oral corticosteroids. See protocol page 27 for details.
