Pulmonary Disease, Chronic ObstructiveNCT03436511
Burden of Disease Among Subjects With Eosinophilic Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 341 participants
- Where
- 4 sitesSpain
- Study dates
- 5 Dec 2017to 10 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Spain4 sites
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Valencia, 46017
About this study
Official title: Burden of Disease Among Patients With Eosinophilic COPD in Spain: Multicentre Observational Study
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
- Keywords
- Health resource utilization, Eosinophilic COPD, Mepolizumab
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects requiring COPD maintenance treatment and rescue medication
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.
Measured: 12 months prior to the inclusion visit
Number of subjects with moderate and severe exacerbations
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.
Measured: 12 months prior to the inclusion visit
Number of subjects with COPD-related scheduled and unscheduled primary and secondary care visits
Subjects with COPD-related scheduled and unscheduled primary and secondary care visits will be analyzed.
Measured: 12 months prior to the inclusion visit
Number of subjects with COPD-related emergency visits to primary care and hospital
Subjects with COPD-related emergency visits to primary care and hospital will be analyzed.
Measured: 12 months prior to the inclusion visit
Number of subjects with COPD-related hospitalizations
Subjects with COPD-related hospitalizations will be analyzed.
Measured: 12 months prior to the inclusion visit
Number of days of hospitalizations
The number of days of hospitalization for subjects will be analyzed.
Measured: 12 months prior to the inclusion visit
Number of subjects with COPD-related complementary tests
Subjects with COPD-related complementary tests will be analyzed.
Measured: 12 months prior to the inclusion visit
Number of subjects with COPD-related days-off work
Subjects with COPD-related days-off work will be analyzed.
Measured: 12 months prior to the inclusion visit
Secondary outcomes (8)
Subjects age as a measure of sociodemographic characteristics
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.
Measured: 4 months (inclusion period)
Number of subjects with different gender
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.
Measured: 4 months (inclusion period)
Number of subjects with different sociodemographic variables
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.
Measured: 4 months (inclusion period)
Number of subjects with abnormal clinical variables
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.
Measured: 4 months (inclusion period)
Number of subjects with abnormal COPD related variables
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.
Measured: 12 months prior to the inclusion visit
Number of subjects with abnormal blood cell count
Peripheral blood eosinophil count, peripheral blood neutrophil count, peripheral blood leukocyte count, fibrinogen and red cell distribution width will be assessed for abnormalities.
Measured: 12 months prior to the inclusion visit
COPD Assessment Test (CAT) score as a measure of Health Related Quality of Life (HRQoL)
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.
Measured: 4 months (inclusion period)
EuroQOL five dimensions five level (EQ-5D-5L) score as a measure of HRQoL
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).
Measured: 4 months (inclusion period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start5 Dec 2017
- Primary completion31 Oct 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oblikue Consulting
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineGSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436511
- Sponsor's protocol ID
- 206555
- Status last verified
- Jan 2019
- First submitted
- 12 Feb 2018
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Disease Among Patients With Eosinophilic COPD in Spain: Multicentre Observational Study
- ClinicalTrials.gov ID
- NCT03436511
- Acronym / sponsor ID
- 206555
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Health resource utilization, Eosinophilic COPD, Mepolizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Oblikue Consulting
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Subjects age as a measure of sociodemographic characteristics
Time frame: 4 months (inclusion period)
Number of subjects with different gender
Time frame: 4 months (inclusion period)
Number of subjects with different sociodemographic variables
Time frame: 4 months (inclusion period)
Number of subjects with abnormal clinical variables
Time frame: 4 months (inclusion period)
Number of subjects with abnormal COPD related variables
Time frame: 12 months prior to the inclusion visit
Number of subjects with abnormal blood cell count
Time frame: 12 months prior to the inclusion visit
COPD Assessment Test (CAT) score as a measure of Health Related Quality of Life (HRQoL)
Time frame: 4 months (inclusion period)
EuroQOL five dimensions five level (EQ-5D-5L) score as a measure of HRQoL
Time frame: 4 months (inclusion period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects requiring COPD maintenance treatment and rescue medication (time frame: 12 months prior to the inclusion visit). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.