A Study to Evaluate the Effect of Umeclidinium (UMEC) as Combination Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Summary

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.

Timeline

Start

2014-09-30

Primary completion

2015-03-24

Completion

2015-03-24

Publications

• Sousa AR, Riley JH, Church A, Zhu CQ, Punekar YS, Fahy WA. The effect of umeclidinium added to inhaled corticosteroid/long-acting beta2-agonist in patients with symptomatic COPD: a randomised, double-blind, parallel-group study. NPJ Prim Care Respir Med. 2016 Jun 23;26:16031. doi: 10.1038/npjpcrm.2016.31.

Drugs

Indications