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Sex Differences in responses to umeclidinium-vilanterol treatment in COPD patients
Proposal
1752
Title of 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
[{ "PostingID": 2543, "Title": "GSK-DB2114417", "Description": "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
Medicine: umeclidinium bromide/vilanterol, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 3, Clinical Study ID: DB2114417, Sponsor: GSK" },{ "PostingID": 2544, "Title": "GSK-DB2114418", "Description": "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
Medicine: umeclidinium bromide/vilanterol, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 3, Clinical Study ID: DB2114418, Sponsor: GSK" }]
Statistical Analysis Plan
The statistical analysis plan will be added after the research is published.
Publication Citation
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