NCT03436511

Burden of Disease Among Subjects With Eosinophilic Chronic Obstructive Pulmonary Disease (COPD)

Burden of Disease Among Patients With Eosinophilic COPD in Spain: Multicentre Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 341 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This observational study is designed to more specifically describe the burden of the disease and the use of healthcare resources of subjects with eosinophilic COPD that may be eligible in the future for a biologic treatment. Subjects who attend a routine follow-up visit and fulfill the inclusion/exclusion criteria defined provide a signed informed consent will be invited by the investigator to participate in this study. Subjects will be recruited in hospital Pulmonology Services across Spain. It is planned to include approximately 20 centers. To select the final participating centers, a feasibility study has been carried out in approximately 50 potential participating centers. It has been estimated that each investigator will include 18 subjects during the 4-month inclusion period. Total 354 subjects will be required: 250 subjects with an eosinophil level \>=150 cells per microliter and 104 subjects with an eosinophil level \<150 cells per microliter. The study inclusion period will be 4 months (expected to be from November 2017 to March 2018) and the retrospective data collection period will be 12 months prior to the inclusion visit.

Conditions

• Pulmonary Disease, Chronic Obstructive

Timeline

• Start date: 2017-12-05
• Primary completion: 2018-10-31
• Completion: 2018-12-10
• First posted: 2018-02-19
• Last updated: 2019-01-29

Locations

4 sites across 1 country: Spain