Comparative Study of Umeclidinium/Vilanterol (UMEC/VI) in a Fixed Dose Combination With Indacaterol Plus Tiotropium
Status:
Completed
Trial end date:
2015-05-04
Target enrollment:
Participant gender:
Summary
This is a Phase IIIb multicentre, randomised, blinded, triple dummy, parallel group study to
evaluate the efficacy and safety of UMEC/VI inhalation powder (62.5/25 microgram [mcg] Once
daily [QD]) when administered via ELLIPTA® Dry Powder Inhaler (DPI) compared to indacaterol
plus tiotropium (150 mcg/18 mcg respectively QD) administered via individual inhalers over a
treatment period of 12 weeks in participants with moderate to very severe Chronic Obstructive
Pulmonary Disease (COPD). The purpose of this study is to demonstrate that UMEC/VI (delivered
via ELLIPTA DPI), when used in symptomatic moderate to very severe COPD participants, is
non-inferior to the combination of indacaterol (delivered via BREEZHALER® inhaler) plus
tiotropium (delivered via HANDIHALER® inhaler) on measures of trough forced expiratory volume
in one second (FEV1) after 12 weeks of treatment. Participants who met the eligibility
criteria at screening (Visit 1) will complete a 5 to 7 day run in period prior to
randomisation at Visit 2. Clinic visits will follow at day 2, week 2, week 4, week 8 and week
12 of treatment, plus week 12 + 1 day (Visits 3 to 8). The total duration of study
participation will be approximately 14 weeks. ELLIPTA is a registered trademark of the GSK
group of companies. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH
& Co. KG. BREEZHALER is a registered trademark of Novartis AG.