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

ID: NCT03436511
Status: Recruiting
Phase: N/A
Start Date: December 05, 2017
First Submitted: February 12, 2018
Last Updated: February 22, 2018
Results: N/A
Organization: GlaxoSmithKline
Sponsors & Collaborators: GlaxoSmithKline, Oblikue Consulting
Location: Spain
Conditions: Pulmonary Disease, Chronic Obstructive
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Pulmonary Disease, Chronic Obstructive

N/A

Tracking Information

First Submitted DateFebruary 12, 2018
Last Update Posted DateFebruary 22, 2018
Actual Start DateDecember 05, 2017
Anticipated Completion DateJuly 31, 2018
Actual Primary Completion DateJuly 31, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Number of subjects requiring COPD maintenance treatment and rescue medication [Time Frame: 12 months prior to the inclusion visit]

    Subjects currently exposed to inhaled triple maintenance therapy, defined as at least one overlapping prescription of an inhaled corticosteroid (ICS) with a long-acting beta2-agonist (LABA) and with a long-acting muscarinic antagonist (LAMA) in 2 or 3 inhaler devices, without more than 30 days of separation between prescriptions along with rescue medication use will be analyzed.

  • Number of subjects with moderate and severe exacerbations [Time Frame: 12 months prior to the inclusion visit]

    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.

  • Number of subjects with COPD-related scheduled and unscheduled primary and secondary care visits [Time Frame: 12 months prior to the inclusion visit]

    Subjects with COPD-related scheduled and unscheduled primary and secondary care visits will be analyzed.

  • Number of subjects with COPD-related emergency visits to primary care and hospital [Time Frame: 12 months prior to the inclusion visit]

    Subjects with COPD-related emergency visits to primary care and hospital will be analyzed.

  • Number of subjects with COPD-related hospitalizations [Time Frame: 12 months prior to the inclusion visit]

    Subjects with COPD-related hospitalizations will be analyzed.

  • Number of days of hospitalizations [Time Frame: 12 months prior to the inclusion visit]

    The number of days of hospitalization for subjects will be analyzed.

  • Number of subjects with COPD-related complementary tests [Time Frame: 12 months prior to the inclusion visit]

    Subjects with COPD-related complementary tests will be analyzed.

  • Number of subjects with COPD-related days-off work [Time Frame: 12 months prior to the inclusion visit]

    Subjects with COPD-related days-off work will be analyzed.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Subjects age as a measure of sociodemographic characteristics [Time Frame: 4 months (inclusion period)]

    Age will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in the study. A threshold of >=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis.

  • Number of subjects with different gender [Time Frame: 4 months (inclusion period)]

    Gender will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in the study. A threshold of >=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis.

  • Number of subjects with different sociodemographic variables [Time Frame: 4 months (inclusion period)]

    Subjects with different educational level, employment status, monthly net income will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in the study A threshold of >=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis.

  • Number of subjects with abnormal clinical variables [Time Frame: 4 months (inclusion period)]

    Clinical variables comprising weight, height, body mass index (self-calculated), smoking history, Charlson comorbidity index, diagnosis of asthma will be assessed for abnormalities. A threshold of >=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis.

  • Number of subjects with abnormal COPD related variables [Time Frame: 12 months prior to the inclusion visit]

    COPD variables comprising COPD diagnosis date, pulmonary function with bronchodilator test, modified Medical Research Council (mMRC) dyspnea scale, clinical phenotypes according to Spanish COPD Clinical Guidelines (GesEPOC) criteria will be assessed for abnormalities. A threshold of >=150 cells/microliter will be considered to determine a high level of eosinophil's, so only subjects meeting this criterion will be included in the analysis.

  • Number of subjects with abnormal blood cell count [Time Frame: 12 months prior to the inclusion visit]

    Peripheral blood eosinophil count, peripheral blood neutrophil count, peripheral blood leukocyte count, fibrinogen and red cell distribution width will be assessed for abnormalities.

  • COPD Assessment Test (CAT) score as a measure of Health Related Quality of Life (HRQoL) [Time Frame: 4 months (inclusion period)]

    The CAT questionnaire is a COPD-specific questionnaire that measures the impact of the disease on HRQoL and allows symptoms to be described. It consists of 8 items, which yield a score range from 0 to 40, 0 representing the lowest impact on HRQoL and 40 the maximum impact.

  • EuroQOL five dimensions five level (EQ-5D-5L) score as a measure of HRQoL [Time Frame: 4 months (inclusion period)]

    The EQ-5D-5L is a preference-based generic HRQoL questionnaire, consisting on five health dimensions (mobility, personal care, daily activities, pain/discomfort and anxiety/depression), divided in five levels of severity (no problems, slight problems, moderate problems, severe problems and extreme problems). It included also a visual analogue scale (VAS) in which respondents are asked to evaluate their overall health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleBurden of Disease Among Subjects With Eosinophilic Chronic Obstructive Pulmonary Disease (COPD)
Official TitleBurden of Disease Among Patients With Eosinophilic COPD in Spain: Multicentre Observational Study
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.

Detailed Description

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
354
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Pulmonary Disease, Chronic Obstructive
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationSubjects 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.
Intervention
Not Available
Study Groups/Cohorts
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.

Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Recruiting
Enrollment354
Completion DateJuly 31, 2018
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.
GenderAll
Age40 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Spain

Administrative Information

NCT Number:NCT03436511
Other Study ID Numbers
206555
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
GlaxoSmithKline
Collaborators
Oblikue Consulting
Investigators
Study Director
GSK Clinical Trials
GlaxoSmithKline