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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03436511

206555

Details and patient eligibility

About

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.

Enrollment: 341 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

341 participants in 1 patient group

Subjects with COPD

Description:

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.