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Proposal 1752

Title of the Proposed Research

Sex Differences in responses to umeclidinium-vilanterol treatment in COPD patients

Lead Researcher

Elisabetta Straface

Affiliation

Istituto superiore di sanità, Italy

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

24 May 2017

Lay Summary

Chronic obstructive pulmonary disease is responsible for early mortality, high death rates and significant cost to health systems. The projection for 2020 indicates that chronic obstructive pulmonary disease will be the third leading cause of death worldwide (from sixth in 1990) and fifth leading cause of years lost through early mortality or handicap (disability-adjusted life years) (12th in 1990). Active smoking remains the main risk factor, but other factors are becoming better known, such as occupational factors, infections and the role of air pollution.

Prevalence of chronic obstructive pulmonary disease varies according to country, age and sex. This disease is also associated with significant comorbidities and it is a disorder that includes various phenotypes, the continuum of which remains under debate. The major challenge in the coming years will be to prevent onset of smoking along with early detection of the disease in the general population.

The objective of the proposal will be to detect differences between male and female chronic obstructive pulmonary disease patients in the efficacy of bronchodilators (umeclidinium/vilanterol) making an analysis of respiratory volumes using the spirometry. Subsequent evidences of significant difference between sexes will provide clinicians with useful elements to make decision for personalized treatment.

Study Data Provided

GSK-DB2114417: 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
GSK-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

Publication Citation

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Summary Results

Results summary or link will be posted when available.