Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomized, Parallel Group Study to Evaluate the Effect of Umeclidinium (UMEC) Added to Inhaled Corticosteroid/ Long-acting Beta-agonist Combination Therapy in Subjects With Chronic Obstructive Pulmonary Disease COPD
This is a multicenter, randomized, double-blind, parallel-group study to evaluate the
efficacy and safety of the addition of UMEC (62.5 microgram[mcg]) when administered
once-daily via dry powder inhaler (DPI) to Inhaled corticosteroid/ Long-acting beta2-agonist
(ICS/LABA) twice-daily compared with placebo via DPI added to the ICS/LABA therapy over a
treatment period of 12 weeks in subjects with COPD. This study is designed to investigate
the addition of UMEC to ICS/LABA combinations at approved doses and frequencies for the
treatment of COPD including SERETIDE™ 500/50 mcg twice daily, Fluticasone
Propionate/Salmeterol Combination (FSC) 500/50 twice daily generic products such as
AIRFLUSAL FORSPIRO inhaler 500/50 mcg twice daily or ROLENIUM ELPENHALER inhaler 500/50 mcg
twice daily and SYMBICORT TURBUHALER inhaler at doses of 200/6 mcg twice daily and 400/12
mcg twice daily, over 12 weeks in subjects with COPD. Albuterol/salbutamol
metered-dose-inhaler (MDI) or nebules will be issued throughout the study for use as-needed
(prn).
Subjects who meet the eligibility criteria will be randomly assigned to one of the following
blinded study treatment regimens in equal proportion (1:1): UMEC 62.5 mcg once-daily and
Placebo once-daily. Approximately 230 subjects (115 subjects per treatment) will be
randomized in order to complete at least 206 evaluable subjects. The total duration of the
study will be approximately 14 weeks for each subject.
UMEC is a Long-acting Muscarinic Antagonist (LAMA) currently under development as a
monotherapy, as a combination product with a LABA, vilanterol (VI), for the treatment of
COPD, and as a combination product with an ICS, fluticasone furoate (FF), for the treatment
of asthma. The UMEC/VI combination 62.5/25 .mcg once-daily has been approved in the United
States (U.S.) and Canada for COPD under the trade name ANORO™ ELLIPTA™ and is under
regulatory review in other countries.
SERETIDE, ANORO, and ELLIPTA are trade marks of the GlaxoSmithKline Group of Companies.
Other company or product names mentioned herein may be the property of their respective
owners.
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