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Proposal 1002

Title of the Proposed Research

Long-acting beta2-agonists and long-acting muscarinic antagonists in a combined inhaler versus either agent alone or placebo for chronic obstructive pulmonary disease

Lead Researcher

Michael Sarai

Affiliation

Kansas City University of Medicine & Biosciences
Kansas City, MO
US

Funding Source

None

Potential Conflicts of Interest

Lead Researcher: None

Researcher 1: Dr. Sin served on advisory boards of Almirall, Novartis, AstraZeneca, Merck, Takeda and Grifols. He has received research funding from AstraZeneca & GlaxoSmithKline. He has received honorarium for speaking engagements from Boehringer Ingelheim, AstraZeneca, and Takeda.

Researcher 2: Dr. FitzGerald has been a member of advisory boards or speaker’s bureau for the following pharmaceutical companies: Astra-Zeneca, GSK, Merck. Boehringer Ingelheim , Novartis and Aerocrine.

Researcher 3: Dr. Aaron has served on advisory boards of Almirall, Novartis, AstraZeneca, and Boehringer Ingelheim. He has received honorarium for speaking engagements from Boehringer Ingelheim

Management of Real or Potential Conflicts of Interest

We will disclose COIs in all publications

Data Sharing Agreement Date

16 June 2014

Lay Summary

Background The latest US Center for Disease Control figures estimates a prevalence of 6.3% (CDC 2012) in the United States. The clinical burden of COPD is substantial. The disease increases the risk of death, and has numerous associated co-morbidities, including: lung cancer, ischaemic heart disease, atrial fibrillation, heart failure, mood disorders, and metabolic syndrome. Worldwide, COPD was the fifth-leading cause of death in 2011, and the seventh-leading cause of lost DALYs (where one DALY is equal to one year of healthy life) (WHO 2013). COPD also has a significant economic impact on society. For example, in Canada, COPD accounts for more hospital admissions than any other major chronic condition (CIHI 2008). Owing largely to costly hospital care, the annual cost of COPD in Canada is $1.5 billion ($105 per $100 000 GDP) (Mittmann 2008).

COPD is treatable, but not curable. The current treatment strategy is multi-modal. Interventions include bronchodilators. Until recently, a prescription for bronchdilators required patients to use two separate inhalers: one for tiotropium, and another for either salmeterol or formoterol. As of early 2014, the following single-inhaler combinations are either on market or in late-phase trials:

Aclidnium/formoterol (herein ACL/FOR)
Glycopyrronium/indacaterol (herein GLY/IND)
Umeclidinium/vilanterol (herein (UME/VIL)
Tiotropium/olodaterol (herein TIO/OLO)

Why it is important to do this review
A systematic review and meta-analysis is required to assess the effects of these products on possible prevention of exacerbations and to assess their heart safety since the individual randomized, controlled registration trials are underpowered to assess these important outcomes.

Objectives
To assess the effects of single-inhaler LABA/LAMA combinations on clinically meaningful outcomes in patients with stable COPD by pooling data from all individual trials. The findings will be communicated to the public via publication in the Cochrane Library.

Study Data Provided

Study DB2113361: A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily via a Novel Dry Powder Inhaler in Subjects with Chronic Obstructive Pulmonary Disease
Study DB2113373: A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily via a Novel Dry Powder Inhaler in Subjects with Chronic Obstructive Pulmonary Disease
Study DB2113374: A multi-center trial comparing the efficacy and safety of GSK573719/GW642444 with GSK573719 and with tiotropium over 24 weeks in subjects with COPD
Study DB2113360: A multicenter trial comparing the efficacy and safety of GSK573719/GW642444 with GW642444 and with tiotropium over 24 weeks in subjects with COPD
Study DB2113359: A 52 week Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 125mcg once-daily alone and in combination with GW642444 25mcg once-daily via novel Dry Powder Inhaler (nDPI) in Subjects with Chronic Obstructive Pulmonary Disease
Study DMD114417: An exercise endurance study to evaluate the effects of treatment of Chronic Obstructive Pulmonary Disease (COPD) patients with a dual bronchodilator: GSK573719/GW642444. Study A
Study DB2114418: An exercise endurance study to evaluate the effects of treatment of Chronic Obstructive Pulmonary Disease (COPD) patients with a dual bronchodilator: GSK573719/GW642444. Study B

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation