Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease characterized by persistent and progressive airway narrowing and airflow limitation. In 2013, the prevalence of COPD among persons 40 years of age and older in the United Kingdom and the United States was 8.1% and 6.7%, respectively. In the UK, men are more affected than women, while the situation in US is reversed.
Although COPD has been considered traditionally a disease of "elderly men", both prevalence and mortality rates have increased more in women than in men in the last years, and the number of new cases of COPD is growing nearly three times faster in women than in men.
Despite a growing body of evidence conducted in real world settings examining key disease features such as the rate of lung function deterioration, annual rate of exacerbation, severity of exacerbations, and other important disease features, only few have systematically examined gender differences across these features. This information could improve patient care and help understand the nature of COPD in women. The aim of this study is to compare the differences between women and men diagnosed with COPD in several key dimensions of COPD (severity, baseline characteristics, and risk of exacerbations).
The objective is to compare women and men with incident COPD diagnosis regarding to the risk of exacerbations, severity of COPD at baseline and during follow-up. Specifically, the primary objective is to compare the hazard ratio of first exacerbation between women and men, and the secondary objectives are to compare the annual rate of exacerbation, the forced expiratory volume in 1 second (FEV1), FEV1 percent predicted, FEV1/FVC (forced vital capacity), the Modified British Medical Research Council Dyspnea Scale (mMRC), and GOLD COPD category at baseline, and FEV1 and mMRC during follow-up. The cohort of incident patients with COPD between 01 January 2010 and 31 December 2015 will be selected among the Clinical Practice Research Datalink (CPRD) subset of patients linking with Hospital Episode Statistics (HES) dataset. Descriptive statistics will be produced to compare women and men's characteristics at baseline; multivariable regression models will be fitted to estimate hazard ratio of first exacerbation, exacerbation rates, and changes in FEV1 and mMRC during follow-up, between women and men.
- Primary: Hazard Ratio of time to first COPD exacerbation between women and men - Secondary: Annual Rate of COPD exacerbation - Secondary: FEV1, FEV1 % predicted, FEV1/FVC, mMRC, and GOLD combined COPD assessment category at baseline - Secondary: Change in FEV1 and mMRC at 1 year, 2 years, and 3 years from baseline
Emil Loefroth - Chief Investigator - NOVARTIS
Valentino Conti - Corresponding Applicant - Not from an Organisation
Andreas Clemens - Collaborator - NOVARTIS
Florian Gutzwiller - Collaborator - University of Basel
Hui Cao - Collaborator - NOVARTIS
Konstantinos Kostikas - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Paul McDwyer - Collaborator - UCB Biopharma SRL - Belgium Headquarters
Robert Fogel - Collaborator - NOVARTIS
HES Accident and Emergency;HES Admitted Patient Care;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation