Study identification

EU PAS number

EUPAS4093

Study ID

42072

Official title and acronym

WEUSKOP6416: Evaluating severe events in patients with Chronic Obstructive Pulmonary Disease (COPD) to inform risk minimization: A Retrospective Observational Study (116952)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

The overall objectives COPD cohort study were to estimate the association between risk factors and pneumonia, including ICS-containing medications and to evaluate differences in clinical characteristics between patients who do and do not develop pneumonia. This is a retrospective observational study in the UK used linked primary and secondary care data with vital statistics. Patients were required to be new users of inhaled-corticosteroid-containing medications or long-acting bronchodilators from 2002-2010. Patients were ≥ 45 years of age, with ≥1 year of data prior to cohort entry for assessment of patient characteristics. Pneumonia events were compared using Cox models using propensity scores to control for confounding. New users were censored at earliest of: pneumonia event, death, switching/stopping treatment, or end of study period. Sensitivity of the results to different pneumonia definitions was evaluated in addition to varying the lag time before pneumonia events.

Study status

Finalised

Contact details

GSK Clinical Disclosure Advisor GSK Clinical Disclosure Advisor cdr_mailbox@gsk.com

Study contact
cdr_mailbox@gsk.com

Darnella Streeter-Edwards Regulated Clinical Support Consultant

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline- R&D
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable