Clinical trial NCT03436511: Burden of Disease Among Subjects With Eosinophilic Chronic Obstructive Pulmonary Disease (COPD)
Official title: Burden of Disease Among Patients With Eosinophilic COPD in Spain: Multicentre Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Health resource utilization
Eosinophilic COPD
Mepolizumab
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Oblikue Consulting
First posted: 2018-02-19
Enrollment: 341
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who attend a routine follow-up visit and who fulfill inclusion/exclusion criteria will be invited by the investigator to participate in the study. The study inclusion period will be four months (from November 2017 to March 2018) and the retrospective data collection period will be 12 months prior to the inclusion visit.

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.


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.

Primary outcomes:
measure: Number of subjects requiring COPD maintenance treatment and rescue medication
timeFrame: 12 months prior to the inclusion visit
measure: Number of subjects with moderate and severe exacerbations
timeFrame: 12 months prior to the inclusion visit
measure: Number of subjects with COPD-related scheduled and unscheduled primary and secondary care visits
timeFrame: 12 months prior to the inclusion visit
measure: Number of subjects with COPD-related emergency visits to primary care and hospital
timeFrame: 12 months prior to the inclusion visit
measure: Number of subjects with COPD-related hospitalizations
timeFrame: 12 months prior to the inclusion visit
measure: Number of days of hospitalizations
timeFrame: 12 months prior to the inclusion visit
measure: Number of subjects with COPD-related complementary tests
timeFrame: 12 months prior to the inclusion visit
measure: Number of subjects with COPD-related days-off work
timeFrame: 12 months prior to the inclusion visit
Secondary outcomes:
measure: Subjects age as a measure of sociodemographic characteristics
timeFrame: 4 months (inclusion period)
measure: Number of subjects with different gender
timeFrame: 4 months (inclusion period)
measure: Number of subjects with different sociodemographic variables
timeFrame: 4 months (inclusion period)
measure: Number of subjects with abnormal clinical variables
timeFrame: 4 months (inclusion period)
measure: Number of subjects with abnormal COPD related variables
timeFrame: 12 months prior to the inclusion visit
measure: Number of subjects with abnormal blood cell count
timeFrame: 12 months prior to the inclusion visit
measure: COPD Assessment Test (CAT) score as a measure of Health Related Quality of Life (HRQoL)
timeFrame: 4 months (inclusion period)
measure: EuroQOL five dimensions five level (EQ-5D-5L) score as a measure of HRQoL
timeFrame: 4 months (inclusion period)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: