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

NCT ID: NCT03436511

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 341 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-05
• Study Completion Date: 2018-12-10

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Subjects with COPD

Subjects with a COPD diagnosis confirmed with a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital capacity \<70% recorded at any time in the medical record who have a qualifying peripheral blood eosinophil test recorded in the 3 months prior to the inclusion visit attend to a routine follow-up visit during the inclusion period, fulfill the inclusion/exclusion criteria and provide informed consent to participate, will be included in this study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Subjects of both sexes aged >=40 years.
• Subjects with a COPD diagnosis confirmed with a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital capacity <70% recorded at any time in the medical record.
• Subjects with a history of smoking (current or past) >=10 pack-years.
• Subjects who have a qualifying peripheral blood eosinophil test recorded in the 3 months prior to the inclusion visit. If the subject has several eosinophil test recorded in this period, the one closest to the inclusion visit determined in the stable phase should be selected; if it is not available, the record closest to the inclusion visit will be selected, even if it has been determined during an exacerbation. If no records are available, the subject will be invited to perform the test at the inclusion visit.
• Subjects currently exposed to inhaled triple maintenance therapy, defined as at least one overlapping prescription of an ICS with a LABA and with a LAMA in 2 or 3 inhaler devices, without more than 30 days of separation between prescriptions.
• Subjects who have experienced >=2 moderate exacerbations or >=1 severe exacerbation in the 12 months prior to the inclusion visit. Moderate exacerbation is defined as an exacerbation requiring antibiotics and/or oral corticosteroids or requiring an emergency visit <24 hours (without hospitalization). Severe exacerbation is defined as an exacerbation requiring hospitalization.
• Subjects who consent to participate in the study by signing the subjects written informed consent form.

Exclusion Criteria

• Subjects without a qualifying peripheral blood eosinophil test recorded in the 3 months prior to the inclusion visit and who refuse to perform the test during the inclusion visit.
• Subjects treated with oral corticosteroids continuously during the 12 months prior to the inclusion visit.
• Subjects with a diagnosis of Churg-Strauss disease, hypereosinophilic syndrome, allergic bronchopulmonary aspergillosis or other conditions that result in increased eosinophil levels independently of COPD.
• Subjects with oncologic disease undergoing treatment or with advanced oncologic disease (without possibility of remission), terminal subjects and/or subjects receiving palliative care.
• Cognitively impaired subjects who are not able to understand or complete the informed consent and HRQoL questionnaires.
• Subjects who have participated in an interventional clinical trial during the 12 months prior to the inclusion visit.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oblikue Consulting

UNKNOWN

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Locations

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Valencia, , Spain

Countries

Spain

Other Identifiers

206555

Identifier Type: -

Identifier Source: org_study_id