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
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
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. This is a randomized, open-label, effectiveness, phase 4 study of 24 weeks' duration in COPD subjects to evaluate TRELEGY ELLIPTA (fluticasone furoate [FF]/vilanterol [VI]/umeclidinium bromide [UMEC]: 100 microgram [mcg]/62.5 mcg/25 mcg) inhalation powder taken once daily using a single ELLIPTA inhaler compared with any non-ELLIPTA MITT in the usual care setting. Effectiveness of TRELEGY ELLIPTA will be assessed by comparing proportion of COPD Assessment Test (CAT) responders at Week 24 between two treatment groups. TRELEGY and ELLIPTA are trademarks of GlaxoSmithKline (GSK) group of companies. The study will enroll approximately 3000 subjects.
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Exclusion Criteria:
Garmisch-Partenirchen, Bavaria 82467, Germany
Marbella - Málaga, Andalusia 29603, Spain
Alzira/Valencia, 46600, Spain
Basurto/Bilbao, 48013, Spain
Benalmádena, Málaga, 29630, Spain
L'Hospitalet de Llobregat. Barcelona, 08907, Spain
Loja/ Granada, 18300, Spain
Pozuelo de Alarcón/Madrid, 28223, Spain
Vigo-Pontevedra, 36312, Spain
Cornwall, TR27 5DT, United Kingdom
Irlam, Manchester, M44 5LH, United Kingdom
Larbet, FK5 4WR, United Kingdom
Newport, Isle of Wight, PO30 5TG, United Kingdom